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1. Haematological consequences of acute uncomplicated falciparum malaria: a WorldWide Antimalarial Resistance Network pooled analysis of individual patient data

Author

Mansoor, R, Commons, RJ, Douglas, NM, Abuaku, B, Achan, J, Adam, I, Adjei, GO, Adjuik, M, Alemayehu, BH, Allan, R, Allen, EN, Anvikar, AR, Arinaitwe, E, Ashley, EA, Ashurst, H, Asih, PBS, Bakyaita, N, Barennes, H, Barnes, K, Basco, L, Bassat, Q, Baudin, E, Bell, DJ, Bethell, D, Bjorkman, A, Boulton, C, Bousema, T, Brasseur, P, Bukirwa, H, Burrow, R, Carrara, V, Cot, M, D'Alessandro, U, Das, D, Das, S, Davis, TME, Desai, M, Djimde, AA, Dondorp, AM, Dorsey, G, Drakeley, CJ, Duparc, S, Espie, E, Etard, J-F, Falade, C, Faucher, JF, Filler, S, Fogg, C, Fukuda, M, Gaye, O, Genton, B, Rahim, AG, Gilayeneh, J, Gonzalez, R, Grais, RF, Grandesso, F, Greenwood, B, Grivoyannis, A, Hatz, C, Hodel, EM, Humphreys, GS, Hwang, J, Ishengoma, D, Juma, E, Kachur, SP, Kager, PA, Kamugisha, E, Kamya, MR, Karema, C, Kayentao, K, Kazienga, A, Kiechel, J-R, Kofoed, P-E, Koram, K, Kremsner, PG, Lalloo, DG, Laman, M, Lee, SJ, Lell, B, Maiga, AW, Martensson, A, Mayxay, M, Mbacham, W, McGready, R, Menan, H, Menard, D, Mockenhaupt, F, Moore, BR, Muller, O, Nahum, A, Ndiaye, J-L, Newton, PN, Ngasala, BE, Nikiema, F, Nji, AM, Noedl, H, Nosten, F, Ogutu, BR, Ojurongbe, O, Osorio, L, Ouedraogo, J-B, Owusu-Agyei, S, Pareek, A, Penali, LK, Piola, P, Plucinski, M, Premji, Z, Ramharter, M, Richmond, CL, Rombo, L, Rosenthal, PJ, Salman, S, Same-Ekobo, A, Sibley, C, Sirima, SB, Smithuis, FM, Some, FA, Staedke, SG, Starzengruber, P, Strub-Wourgaft, N, Sutanto, I, Swarthout, TD, Syafruddin, D, Talisuna, AO, Taylor, WR, Temu, EA, Thwing, J, Tinto, H, Tjitra, E, Toure, OA, Tran, TH, Ursing, J, Valea, I, Valentini, G, van Vugt, M, von Seidlein, L, Ward, SA, Were, V, White, NJ, Woodrow, CJ, Yavo, W, Yeka, A, Zongo, I, Simpson, JA, Guerin, PJ, Stepniewska, K, Price, RN, Roper, C, Mansoor, R, Commons, RJ, Douglas, NM, Abuaku, B, Achan, J, Adam, I, Adjei, GO, Adjuik, M, Alemayehu, BH, Allan, R, Allen, EN, Anvikar, AR, Arinaitwe, E, Ashley, EA, Ashurst, H, Asih, PBS, Bakyaita, N, Barennes, H, Barnes, K, Basco, L, Bassat, Q, Baudin, E, Bell, DJ, Bethell, D, Bjorkman, A, Boulton, C, Bousema, T, Brasseur, P, Bukirwa, H, Burrow, R, Carrara, V, Cot, M, D'Alessandro, U, Das, D, Das, S, Davis, TME, Desai, M, Djimde, AA, Dondorp, AM, Dorsey, G, Drakeley, CJ, Duparc, S, Espie, E, Etard, J-F, Falade, C, Faucher, JF, Filler, S, Fogg, C, Fukuda, M, Gaye, O, Genton, B, Rahim, AG, Gilayeneh, J, Gonzalez, R, Grais, RF, Grandesso, F, Greenwood, B, Grivoyannis, A, Hatz, C, Hodel, EM, Humphreys, GS, Hwang, J, Ishengoma, D, Juma, E, Kachur, SP, Kager, PA, Kamugisha, E, Kamya, MR, Karema, C, Kayentao, K, Kazienga, A, Kiechel, J-R, Kofoed, P-E, Koram, K, Kremsner, PG, Lalloo, DG, Laman, M, Lee, SJ, Lell, B, Maiga, AW, Martensson, A, Mayxay, M, Mbacham, W, McGready, R, Menan, H, Menard, D, Mockenhaupt, F, Moore, BR, Muller, O, Nahum, A, Ndiaye, J-L, Newton, PN, Ngasala, BE, Nikiema, F, Nji, AM, Noedl, H, Nosten, F, Ogutu, BR, Ojurongbe, O, Osorio, L, Ouedraogo, J-B, Owusu-Agyei, S, Pareek, A, Penali, LK, Piola, P, Plucinski, M, Premji, Z, Ramharter, M, Richmond, CL, Rombo, L, Rosenthal, PJ, Salman, S, Same-Ekobo, A, Sibley, C, Sirima, SB, Smithuis, FM, Some, FA, Staedke, SG, Starzengruber, P, Strub-Wourgaft, N, Sutanto, I, Swarthout, TD, Syafruddin, D, Talisuna, AO, Taylor, WR, Temu, EA, Thwing, J, Tinto, H, Tjitra, E, Toure, OA, Tran, TH, Ursing, J, Valea, I, Valentini, G, van Vugt, M, von Seidlein, L, Ward, SA, Were, V, White, NJ, Woodrow, CJ, Yavo, W, Yeka, A, Zongo, I, Simpson, JA, Guerin, PJ, Stepniewska, K, Price, RN, and Roper, C

Abstract

BACKGROUND: Plasmodium falciparum malaria is associated with anaemia-related morbidity, attributable to host, parasite and drug factors. We quantified the haematological response following treatment of uncomplicated P. falciparum malaria to identify the factors associated with malarial anaemia. METHODS: Individual patient data from eligible antimalarial efficacy studies of uncomplicated P. falciparum malaria, available through the WorldWide Antimalarial Resistance Network data repository prior to August 2015, were pooled using standardised methodology. The haematological response over time was quantified using a multivariable linear mixed effects model with nonlinear terms for time, and the model was then used to estimate the mean haemoglobin at day of nadir and day 7. Multivariable logistic regression quantified risk factors for moderately severe anaemia (haemoglobin < 7 g/dL) at day 0, day 3 and day 7 as well as a fractional fall ≥ 25% at day 3 and day 7. RESULTS: A total of 70,226 patients, recruited into 200 studies between 1991 and 2013, were included in the analysis: 50,859 (72.4%) enrolled in Africa, 18,451 (26.3%) in Asia and 916 (1.3%) in South America. The median haemoglobin concentration at presentation was 9.9 g/dL (range 5.0-19.7 g/dL) in Africa, 11.6 g/dL (range 5.0-20.0 g/dL) in Asia and 12.3 g/dL (range 6.9-17.9 g/dL) in South America. Moderately severe anaemia (Hb < 7g/dl) was present in 8.4% (4284/50,859) of patients from Africa, 3.3% (606/18,451) from Asia and 0.1% (1/916) from South America. The nadir haemoglobin occurred on day 2 post treatment with a mean fall from baseline of 0.57 g/dL in Africa and 1.13 g/dL in Asia. Independent risk factors for moderately severe anaemia on day 7, in both Africa and Asia, included moderately severe anaemia at baseline (adjusted odds ratio (AOR) = 16.10 and AOR = 23.00, respectively), young age (age < 1 compared to ≥ 12 years AOR = 12.81 and AOR = 6.79, respectively), high parasitaemia (AOR = 1.78 and AOR = 1.

Published
2022

2. Molecular analysis of markers associated with chloroquine and sulfadoxine/pyrimethamine resistance in Plasmodium falciparum malaria parasites from southeastern Côte-d'Ivoire by the time of Artemisinin-based Combination Therapy adoption in 2005

Author

Ako BA, Offianan AT, Johansson M, Penali LK, Nguetta SP, and Sibley CH

Subjects
Infectious and parasitic diseases, RC109-216
Abstract

Berenger Aristide Ako,1 André Toure Offianan,1 Marnie Johansson,2 Louis Koné Penali,1 Simon-Pierre Assanvo Nguetta,3 Carol Hopkin Sibley21Department of Malariology, Institut Pasteur de Côte-d'Ivoire, Abidjan, Côte d'Ivoire; 2Department of Genome Sciences, University of Washington, Seattle, WA, USA; 3Laboratoire de Génétique, Université de Cocody, Abidjan, Côte d'IvoirePurpose: Artemisin-based combination therapies became the recommended therapy in Côte-d'Ivoire in 2005, but both chloroquine (CQ) and sulfadoxine/pyrimethamine (SP) have been heavily used for many decades. Despite this long history, little is known about the geographical distribution of drug resistance–conferring genotypes outside the capital city of Abidjan. In this work, we compared the prevalence of drug-resistant genotypes in Bonoua, an urban area, and Samo, a rural agricultural area, in southeastern Côte-d'Ivoire, about 59 km from Abidjan.Patients and methods: Samples were collected from symptomatic patients in both sites during the rainy season in 2005. Genomic DNA was isolated and codons associated with resistance to CQ and SP were analyzed: pfcrt codons Cys-72-Ser, Val-73-Val, Met-74-Ile, Arg-75-Glu, Lys-76-Thr; pfdhfr codons Ala-16-Val, Arg-51-Ile, Cys-59-Arg, Ser-108-Arg/Thr, and Ile-164-Leu; pfdhps codons Ser-436-Ala, Ala-437-Gly, Lys-540-Glu, Ala-581-Gly, and Ala-613-Thr/Ser.Results: A limited number of genotypes were found in Bonoua compared with Samo. In both sites, the triple-mutant allele CVIET of pfcrt predominated: 100% in Bonoua and 86.2% in Samo. The wild-type allele, NCSI of pfdhfr, was common – 50% in Bonoua and 38.7% in Samo – but the triple-mutant IRNI and double-mutant NRNI were also frequent (IRNI, 32.6% in Bonoua and 19.4% in Samo; NRNI, 15.2% in Bonoua and 9.7% in Samo). In Samo, a wide range of different genotypes of Pfdhps was observed, with alleles carrying the Gly-437 codon fixed in Bonoua and comprising 73% of the isolates in Samo.Conclusion: Although these two sites are only 8 km apart, they belonged to very different ecological environments. The overall prevalence of alleles of single-nucleotide polymorphisms associated with resistance to CQ and SP in both locations was among the highest of the region by 2005, although the more rural site showed a more diverse set of alleles and mixed infections. Continued surveillance of these markers will be a useful tool for drug policy, as both CQ and SP are still frequently used years after withdrawal, and SP is recommended by the World Health Organization for intermittent preventive therapy for pregnant women and infants. Data analyzed herein are among the first to be generated during the year of artemisin-based combination-therapy introduction in Côte-d'Ivoire and could be of some interest for malaria policy-makers.Keywords: Côte-d'Ivoire, malaria resistance, chloroquine, sulfadoxine/pyrimethamine, pfdhfr, pfdhps, pfcrt

Published
2012

3. Comparative efficacy of uncontrolled and controlled intermittent preventive treatment during pregnancy (IPTp) with combined use of LLTNs in high resistance area to sulfadoxine-pyrimethamine in Côte d’Ivoire

Author

Offianan AT, Penali LK, Coulibaly MA, Tiacoh NL, Ako AAB, Adji EG, Coulibaly B, Koffi D, Sarr D, Jambou R, and Kone M

Subjects
Infectious and parasitic diseases, RC109-216
Abstract

A Toure Offianan1, Louis K Penali1, MA Coulibaly1, NL Tiacoh1, AAB Ako1, EG Adji1, B Coulibaly1, D Koffi1, D Sarr2, R Jambou3, M Kone41Department of Malariology, Institut Pasteur of Côte d’Ivoire, 2Department of Infectious Diseases, University of Georgia, Athens, GA, 3Department of Immunology, Institut Pasteur of Madagascar, Tananarive, Madagascar, 4UFR Sciences Pharmaceutiques et Biologiques, University of Cocody, Abidjan, Côte d’IvoireIntroduction: In recent years, intermittent preventive treatment for pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) has become policy in much of sub-Saharan Africa. But resistance to SP has been spreading across sub-Saharan Africa and thus the effectiveness of IPTp-SP has been questioned. The present study therefore sought to assess the incidence of placental malaria, low birth weight, and anemia of two IPTp-SP approaches (directly observed treatment scheme versus no directly observed treatment) in Anonkoua-Kouté and Samo, Côte d’Ivoire where the reported prevalence of dfr single mutant 108 was 62% and 52.2%, respectively.Methods: The study was a longitudinal design involving pregnant women and was conducted in Anonkoua-Kouté, a suburban area, and Samo, a rural area, from January 2008 through March 2009. Women of a pregnancy less than 28 weeks duration were randomized to receive SP (1.5 g/0.075 g SP) in a single intake twice and were followed up monthly until delivery. Doses were administered under supervision in the controlled IPTp group, while SP was given free to women in the uncontrolled IPTp group with a recommendation to take it at home. The primary end point was the proportion of low birth weight infants (body weight < 2500 g) and the secondary end point was the rate of severe anemia and placental malaria detected at delivery.Results: A total of 420 pregnant women were enrolled (212 and 208, respectively, in the controlled and uncontrolled groups). Delivery outcome was available for 378 women. In the modified intention-to-treat analysis, low birth weight infants were born from 15.5% of women of the uncontrolled IPTp group and from 11.9% of women in the controlled IPTp group (P = 0.31). The per-protocol population analysis showed consistent results. The proportion of women with placental malaria infection, moderate anemia (hemoglobin < 11 g/dL), and severe anemia (hemoglobin < 8 g/dL) at delivery were similar between the two groups (P > 0.05).Conclusion: The study showed that the two approaches were equivalent, suggesting that unsupervised IPTp-SP free of charge should be used in areas where implementation of the directly observed treatment scheme suffers from many constraints.Keywords: IPTp, SP efficacy, DOT scheme, resistance, Côte d’Ivoire

Published
2012

4. Assessment of the efficacy of first-line antimalarial drugs after 5 years of deployment by the National Malaria Control Programme in Côte d'Ivoire

Author

Offianan AT, Assi SB, Coulibaly A, N'guessan LT, Ako AA, Kadjo FK, San MK, and Penali LK

Subjects
Medicine
Abstract

Andre T Offianan1, Serge B Assi2, Aristide MA Coulibaly1, Landry T N'guessan1, Aristide A Ako1, Florence K Kadjo2, Moïse K San2, Louis K Penali2 1Malariology Department, Institut Pasteur de Côte d'Ivoire, Abidjan, Côte d'Ivoire; 2National Malaria Control Programme, Abidjan, Côte d'Ivoire Background: The emergence of artemisinin resistance has raised concerns that the most potent antimalarial drug may be under threat. Artesunate + amodiaquine (ASAQ) and artemether-lumefantrine (AL) are respectively the first- and second-line treatments for uncomplicated falciparum malaria in Côte d'Ivoire. A comparison of the efficacy and safety of these two drug combinations was necessary to make evidence-based drug treatment policies. Methods: In an open-label, non inferiority, randomized, controlled clinical trial, children aged 6–59 months were randomized to receive ASAQ or AL. Both drug regimens were given for 3 days, and follow-up was for 28 days. The primary endpoint was the 28-day cure rates and was defined as proportion of patients with polymerase chain reaction (PCR)-corrected cure rate after 28 days of follow-up. Findings: A total of 251 patients who were attending the Ayame and Dabakala hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive ASAQ (128) and AL (123). The intention-to-treat analysis showed effectiveness rates of 94.5% and 93.5% for ASAQ and AL, respectively on day 28. After adjustment for PCR results, these rates were 96.1% and 96.8%, respectively. On day 28, the per-protocol analysis showed effectiveness rates of 98.4% and 96.6% for ASAQ and AL, respectively. After adjustment by PCR for reinfection, these rates were 100% for each drug, and both regimens were well tolerated. Conclusion: ASAQ and AL remain efficacious treatments of uncomplicated falciparum malaria in Ivorian children 5 years after adoption. The efficacy of ASAQ and AL in Côte d'Ivoire requires, therefore, continuous monitoring and evaluation. Keywords: artesunate, amodiaquine, artemether-lumefantrine, ASAQ, AL

Published
2011

5. The effect of dose on the antimalarial efficacy of artemether-lumefantrine: a systematic review and pooled analysis of individual patient data

Author

Anstey, NM, Price, RN, Davis, TME, Karunajeewa, HA, Mueller, I, D'Alessandro, U, Massougbodji, A, Nikiema, F, Ouedraogo, JB, Tinto, H, Zongo, I, Same-Ekobo, A, Kone, M, Menan, H, Toure, AO, Yavo, W, Kofoed, PE, Alemayehu, BH, Jima, D, Baudin, E, Espie, E, Nabasumba, C, Pinoges, L, Schramm, B, Cot, M, Deloron, P, Faucher, JF, Guthmann, JP, Lell, B, Borrmann, S, Adjei, GO, Ursing, J, Tjitra, E, Marsh, K, Peshu, J, Juma, E, Ogutu, BR, Omar, SA, Sawa, P, Talisuna, AO, Khanthavong, M, Mayxay, M, Newton, PN, Piola, P, Djimde, AA, Doumbo, OK, Fofana, B, Sagara, I, Bassat, Q, Gonzalez, R, Menendez, C, Smithuis, F, Bousema, T, Kager, PA, Mens, PF, Schallig, HDFH, van Den Broek, I, van Vugt, M, Ibrahim, ML, Falade, CO, Meremikwu, M, Gil, JP, Karema, C, Ba, MS, Faye, B, Faye, O, Gaye, O, Ndiaye, JL, Pene, M, Sow, D, Sylla, K, Tine, RCK, Penali, LK, Barnes, KI, Workman, LJ, Lima, A, Adam, I, Gadalla, NB, Malik, EFM, Bjorkman, A, Martensson, A, Ngasala, BE, Rombo, L, Aliu, P, Duparc, S, Filler, S, Genton, B, Hodel, EM, Olliaro, P, Abdulla, S, Kamugisha, E, Premji, Z, Shekalaghe, SA, Ashley, EA, Carrara, VI, McGready, R, Nosten, F, Faiz, AM, Lee, SJ, White, NJ, Dondorp, AM, Smith, JJ, Tarning, J, Achan, J, Bukirwa, H, Yeka, A, Arinaitwe, E, Staedke, SG, Kamya, MR, Kironde, F, Drakeley, CJ, Oguike, M, Sutherland, CJ, Checchi, F, Dahal, P, Flegg, JA, Guerin, PJ, Moreira, C, Nsanzabana, C, Sibley, CH, Stepniewska, K, Gething, PW, Hay, SI, Greenwood, B, Ward, SA, Winstanley, PA, Dorsey, G, Greenhouse, B, Rosenthal, PJ, Grivoyannis, A, Hamed, K, Hwang, J, Kachur, PS, and Nambozi, M

Published
2015

6. Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: a literature review and meta-analysis of individual patient data

Author

Abdulla, S, Adam, I, Adjei, GO, Adjuik, MA, Alemayehu, B, Allan, R, Arinaitwe, E, Ashley, EA, Ba, MS, Barennes, H, Barnes, KI, Bassat, Q, Baudin, E, Berens-Riha, N, Bjoerkman, A, Bompart, F, Bonnet, M, Borrmann, S, Bousema, T, Brasseur, P, Bukirwa, H, Checchi, F, Dahal, P, D'Alessandro, U, Desai, M, Dicko, A, Djimde, AA, Dorsey, G, Doumbo, OK, Drakeley, CJ, Duparc, S, Eshetu, T, Espie, E, Etard, J-F, Faiz, AM, Falade, CO, Fanello, CI, Faucher, J-F, Faye, B, Faye, O, Filler, S, Flegg, JA, Fofana, B, Fogg, C, Gadalla, NB, Gaye, O, Genton, B, Gething, PW, Gil, JP, Gonzalez, R, Grandesso, F, Greenhouse, B, Greenwood, B, Grivoyannis, A, Guerin, PJ, Guthmann, J-P, Hamed, K, Hamour, S, Hay, SI, Hodel, EM, Humphreys, GS, Hwang, J, Ibrahim, ML, Jima, D, Jones, JJ, Jullien, V, Juma, E, Kachur, PS, Kager, PA, Kamugisha, E, Kamya, MR, Karema, C, Kayentao, K, Kiechel, J-R, Kironde, F, Kofoed, P-E, Kremsner, PG, Krishna, S, Lameyre, V, Lell, B, Lima, A, Makanga, M, Malik, EM, Marsh, K, Martensson, A, Massougbodji, A, Menan, H, Menard, D, Menendez, C, Mens, PF, Meremikwu, M, Moreira, C, Nabasumba, C, Nambozi, M, Ndiaye, J-L, Ngasala, BE, Nikiema, F, Nsanzabana, C, Ntoumi, F, Oguike, M, Ogutu, BR, Olliaro, P, Omar, SA, Ouedraogo, J-B, Owusu-Agyei, S, Penali, LK, Pene, M, Peshu, J, Piola, P, Plowe, CV, Premji, Z, Price, RN, Randrianarivelojosia, M, Rombo, L, Roper, C, Rosenthal, PJ, Sagara, I, Same-Ekobo, A, Sawa, P, Schallig, HDFH, Schramm, B, Seck, A, Shekalaghe, SA, Sibley, CH, Sinou, V, Sirima, SB, Som, FA, Sow, D, Staedke, SG, Stepniewska, K, Sutherland, CJ, Swarthout, TD, Sylla, K, Talisuna, AO, Taylor, WRJ, Temu, EA, Thwing, JI, Tine, RCK, Tinto, H, Tommasini, S, Toure, OA, Ursing, J, Vaillant, MT, Valentini, G, Van den Broek, I, Van Vugt, M, Ward, SA, Winstanley, PA, Yavo, W, Yeka, A, Zolia, YM, Zongo, I, Abdulla, S, Adam, I, Adjei, GO, Adjuik, MA, Alemayehu, B, Allan, R, Arinaitwe, E, Ashley, EA, Ba, MS, Barennes, H, Barnes, KI, Bassat, Q, Baudin, E, Berens-Riha, N, Bjoerkman, A, Bompart, F, Bonnet, M, Borrmann, S, Bousema, T, Brasseur, P, Bukirwa, H, Checchi, F, Dahal, P, D'Alessandro, U, Desai, M, Dicko, A, Djimde, AA, Dorsey, G, Doumbo, OK, Drakeley, CJ, Duparc, S, Eshetu, T, Espie, E, Etard, J-F, Faiz, AM, Falade, CO, Fanello, CI, Faucher, J-F, Faye, B, Faye, O, Filler, S, Flegg, JA, Fofana, B, Fogg, C, Gadalla, NB, Gaye, O, Genton, B, Gething, PW, Gil, JP, Gonzalez, R, Grandesso, F, Greenhouse, B, Greenwood, B, Grivoyannis, A, Guerin, PJ, Guthmann, J-P, Hamed, K, Hamour, S, Hay, SI, Hodel, EM, Humphreys, GS, Hwang, J, Ibrahim, ML, Jima, D, Jones, JJ, Jullien, V, Juma, E, Kachur, PS, Kager, PA, Kamugisha, E, Kamya, MR, Karema, C, Kayentao, K, Kiechel, J-R, Kironde, F, Kofoed, P-E, Kremsner, PG, Krishna, S, Lameyre, V, Lell, B, Lima, A, Makanga, M, Malik, EM, Marsh, K, Martensson, A, Massougbodji, A, Menan, H, Menard, D, Menendez, C, Mens, PF, Meremikwu, M, Moreira, C, Nabasumba, C, Nambozi, M, Ndiaye, J-L, Ngasala, BE, Nikiema, F, Nsanzabana, C, Ntoumi, F, Oguike, M, Ogutu, BR, Olliaro, P, Omar, SA, Ouedraogo, J-B, Owusu-Agyei, S, Penali, LK, Pene, M, Peshu, J, Piola, P, Plowe, CV, Premji, Z, Price, RN, Randrianarivelojosia, M, Rombo, L, Roper, C, Rosenthal, PJ, Sagara, I, Same-Ekobo, A, Sawa, P, Schallig, HDFH, Schramm, B, Seck, A, Shekalaghe, SA, Sibley, CH, Sinou, V, Sirima, SB, Som, FA, Sow, D, Staedke, SG, Stepniewska, K, Sutherland, CJ, Swarthout, TD, Sylla, K, Talisuna, AO, Taylor, WRJ, Temu, EA, Thwing, JI, Tine, RCK, Tinto, H, Tommasini, S, Toure, OA, Ursing, J, Vaillant, MT, Valentini, G, Van den Broek, I, Van Vugt, M, Ward, SA, Winstanley, PA, Yavo, W, Yeka, A, Zolia, YM, and Zongo, I

Abstract

BACKGROUND: Artemisinin-resistant Plasmodium falciparum has emerged in the Greater Mekong sub-region and poses a major global public health threat. Slow parasite clearance is a key clinical manifestation of reduced susceptibility to artemisinin. This study was designed to establish the baseline values for clearance in patients from Sub-Saharan African countries with uncomplicated malaria treated with artemisinin-based combination therapies (ACTs). METHODS: A literature review in PubMed was conducted in March 2013 to identify all prospective clinical trials (uncontrolled trials, controlled trials and randomized controlled trials), including ACTs conducted in Sub-Saharan Africa, between 1960 and 2012. Individual patient data from these studies were shared with the WorldWide Antimalarial Resistance Network (WWARN) and pooled using an a priori statistical analytical plan. Factors affecting early parasitological response were investigated using logistic regression with study sites fitted as a random effect. The risk of bias in included studies was evaluated based on study design, methodology and missing data. RESULTS: In total, 29,493 patients from 84 clinical trials were included in the analysis, treated with artemether-lumefantrine (n = 13,664), artesunate-amodiaquine (n = 11,337) and dihydroartemisinin-piperaquine (n = 4,492). The overall parasite clearance rate was rapid. The parasite positivity rate (PPR) decreased from 59.7 % (95 % CI: 54.5-64.9) on day 1 to 6.7 % (95 % CI: 4.8-8.7) on day 2 and 0.9 % (95 % CI: 0.5-1.2) on day 3. The 95th percentile of observed day 3 PPR was 5.3 %. Independent risk factors predictive of day 3 positivity were: high baseline parasitaemia (adjusted odds ratio (AOR) = 1.16 (95 % CI: 1.08-1.25); per 2-fold increase in parasite density, P <0.001); fever (>37.5 °C) (AOR = 1.50 (95 % CI: 1.06-2.13), P = 0.022); severe anaemia (AOR = 2.04 (95 % CI: 1.21-3.44), P = 0.008); areas of low/moderate transmission setting (AOR = 2.71 (95 % CI: 1.38

Published
2015

7. The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: a meta-analysis of individual patient data

Author

Adjuik, MA, Allan, R, Anvikar, AR, Ashley, EA, Ba, MS, Barennes, H, Barnes, KI, Bassat, Q, Baudin, E, Bjorkman, A, Bompart, F, Bonnet, M, Borrmann, S, Brasseur, P, Bukirwa, H, Checchi, F, Cot, M, Dahal, P, D'Alessandro, U, Deloron, P, Desai, M, Diap, G, Djimde, AA, Dorsey, G, Doumbo, OK, Espie, E, Etard, J-F, Fanello, CI, Faucher, J-F, Faye, B, Flegg, JA, Gaye, O, Gething, PW, Gonzalez, R, Grandesso, F, Guerin, PJ, Guthmann, J-P, Hamour, S, Hasugian, AR, Hay, SI, Humphreys, GS, Jullien, V, Juma, E, Kamya, MR, Karema, C, Kiechel, JR, Kremsner, PG, Krishna, S, Lameyre, V, Ibrahim, LM, Lee, SJ, Lell, B, Martensson, A, Massougbodji, A, Menan, H, Menard, D, Menendez, C, Meremikwu, M, Moreira, C, Nabasumba, C, Nambozi, M, Ndiaye, J-L, Nikiema, F, Nsanzabana, C, Ntoumi, F, Ogutu, BR, Olliaro, P, Osorio, L, Ouedraogo, J-B, Penali, LK, Pene, M, Pinoges, L, Piola, P, Price, RN, Roper, C, Rosenthal, PJ, Rwagacondo, CE, Same-Ekobo, A, Schramm, B, Seck, A, Sharma, B, Sibley, CH, Sinou, V, Sirima, SB, Smith, JJ, Smithuis, F, Some, FA, Sow, D, Staedke, SG, Stepniewska, K, Swarthout, TD, Sylla, K, Talisuna, AO, Tarning, J, Taylor, WRJ, Temu, EA, Thwing, JI, Tjitra, E, Tine, RCK, Tinto, H, Vaillant, MT, Valecha, N, Van den Broek, I, White, NJ, Yeka, A, Zongo, I, Adjuik, MA, Allan, R, Anvikar, AR, Ashley, EA, Ba, MS, Barennes, H, Barnes, KI, Bassat, Q, Baudin, E, Bjorkman, A, Bompart, F, Bonnet, M, Borrmann, S, Brasseur, P, Bukirwa, H, Checchi, F, Cot, M, Dahal, P, D'Alessandro, U, Deloron, P, Desai, M, Diap, G, Djimde, AA, Dorsey, G, Doumbo, OK, Espie, E, Etard, J-F, Fanello, CI, Faucher, J-F, Faye, B, Flegg, JA, Gaye, O, Gething, PW, Gonzalez, R, Grandesso, F, Guerin, PJ, Guthmann, J-P, Hamour, S, Hasugian, AR, Hay, SI, Humphreys, GS, Jullien, V, Juma, E, Kamya, MR, Karema, C, Kiechel, JR, Kremsner, PG, Krishna, S, Lameyre, V, Ibrahim, LM, Lee, SJ, Lell, B, Martensson, A, Massougbodji, A, Menan, H, Menard, D, Menendez, C, Meremikwu, M, Moreira, C, Nabasumba, C, Nambozi, M, Ndiaye, J-L, Nikiema, F, Nsanzabana, C, Ntoumi, F, Ogutu, BR, Olliaro, P, Osorio, L, Ouedraogo, J-B, Penali, LK, Pene, M, Pinoges, L, Piola, P, Price, RN, Roper, C, Rosenthal, PJ, Rwagacondo, CE, Same-Ekobo, A, Schramm, B, Seck, A, Sharma, B, Sibley, CH, Sinou, V, Sirima, SB, Smith, JJ, Smithuis, F, Some, FA, Sow, D, Staedke, SG, Stepniewska, K, Swarthout, TD, Sylla, K, Talisuna, AO, Tarning, J, Taylor, WRJ, Temu, EA, Thwing, JI, Tjitra, E, Tine, RCK, Tinto, H, Vaillant, MT, Valecha, N, Van den Broek, I, White, NJ, Yeka, A, and Zongo, I

Abstract

Background

Artesunate-amodiaquine (AS-AQ) is one of the most widely used artemisinin-based combination therapies (ACTs) to treat uncomplicated Plasmodium falciparum malaria in Africa. We investigated the impact of different dosing strategies on the efficacy of this combination for the treatment of falciparum malaria.

Methods

Individual patient data from AS-AQ clinical trials were pooled using the WorldWide Antimalarial Resistance Network (WWARN) standardised methodology. Risk factors for treatment failure were identified using a Cox regression model with shared frailty across study sites.

Results

Forty-three studies representing 9,106 treatments from 1999-2012 were included in the analysis; 4,138 (45.4%) treatments were with a fixed dose combination with an AQ target dose of 30 mg/kg (FDC), 1,293 (14.2%) with a non-fixed dose combination with an AQ target dose of 25 mg/kg (loose NFDC-25), 2,418 (26.6%) with a non-fixed dose combination with an AQ target dose of 30 mg/kg (loose NFDC-30), and the remaining 1,257 (13.8%) with a co-blistered non-fixed dose combination with an AQ target dose of 30 mg/kg (co-blistered NFDC). The median dose of AQ administered was 32.1 mg/kg [IQR: 25.9-38.2], the highest dose being administered to patients treated with co-blistered NFDC (median = 35.3 mg/kg [IQR: 30.6-43.7]) and the lowest to those treated with loose NFDC-25 (median = 25.0 mg/kg [IQR: 22.7-25.0]). Patients treated with FDC received a median dose of 32.4 mg/kg [IQR: 27-39.0]. After adjusting for reinfections, the corrected antimalarial efficacy on day 28 after treatment was similar for co-blistered NFDC (97.9% [95% confidence interval (CI): 97.0-98.8%]) and FDC (98.1% [95% CI: 97.6%-98.5%]; P = 0.799), but significantly lower for the loose NFDC-25 (93.4% [95% CI: 91.9%-94.9%]), and loose NFDC-30 (95.0% [95% CI: 94.1%-95.9%]) (P < 0.001 for all comparisons). After controlling for age, AQ dose, baseline parasitemia and region; treatment with loose NFDC-2

Published
2015

8. The Effect of Dosing Regimens on the Antimalarial Efficacy of Dihydroartemisinin-Piperaquine: A Pooled Analysis of Individual Patient Data

Author

Garner, P, Achan, J, Adam, I, Arinaitwe, E, Ashley, EA, Awab, GR, Ba, MS, Barnes, KI, Bassat, Q, Borrmann, S, Bousema, T, Dahal, P, D'Alessandro, U, Davis, TME, Dondorp, AM, Dorsey, G, Drakeley, CJ, Fanello, CI, Faye, B, Flegg, JA, Gaye, O, Gething, PW, Gonzalez, R, Guerin, PJ, Hay, SI, Hien, TT, Janssens, B, Kamya, MR, Karema, C, Karunajeewa, HA, Kone, M, Lell, B, Marsh, K, Mayxay, M, Menendez, C, Mens, PF, Meremikwu, M, Moreira, C, Mueller, I, Nabasumba, C, Nambozi, M, Ndiaye, J-L, Newton, PN, Thuy-Nhien, N, Nosten, F, Nsanzabana, C, Omar, SA, Ouedraogo, J-B, Penali, LK, Pene, M, Phyo, AP, Piola, P, Price, RN, Sasithon, P, Rosenthal, PJ, Same-Ekobo, A, Sawa, P, Schallig, HDFH, Shekalaghe, SA, Sibley, CH, Smith, J, Smithuis, F, Some, AF, Stepniewska, K, Talisuna, AO, Tarning, J, Tjitra, E, Tine, RCK, Tinto, H, Valecha, N, Van Herp, M, Van Vugt, M, White, NJ, Woodrow, CJ, Yavo, W, Yeka, A, Zongo, I, Garner, P, Achan, J, Adam, I, Arinaitwe, E, Ashley, EA, Awab, GR, Ba, MS, Barnes, KI, Bassat, Q, Borrmann, S, Bousema, T, Dahal, P, D'Alessandro, U, Davis, TME, Dondorp, AM, Dorsey, G, Drakeley, CJ, Fanello, CI, Faye, B, Flegg, JA, Gaye, O, Gething, PW, Gonzalez, R, Guerin, PJ, Hay, SI, Hien, TT, Janssens, B, Kamya, MR, Karema, C, Karunajeewa, HA, Kone, M, Lell, B, Marsh, K, Mayxay, M, Menendez, C, Mens, PF, Meremikwu, M, Moreira, C, Mueller, I, Nabasumba, C, Nambozi, M, Ndiaye, J-L, Newton, PN, Thuy-Nhien, N, Nosten, F, Nsanzabana, C, Omar, SA, Ouedraogo, J-B, Penali, LK, Pene, M, Phyo, AP, Piola, P, Price, RN, Sasithon, P, Rosenthal, PJ, Same-Ekobo, A, Sawa, P, Schallig, HDFH, Shekalaghe, SA, Sibley, CH, Smith, J, Smithuis, F, Some, AF, Stepniewska, K, Talisuna, AO, Tarning, J, Tjitra, E, Tine, RCK, Tinto, H, Valecha, N, Van Herp, M, Van Vugt, M, White, NJ, Woodrow, CJ, Yavo, W, Yeka, A, and Zongo, I

Abstract

BACKGROUND: Dihydroartemisinin-piperaquine (DP) is increasingly recommended for antimalarial treatment in many endemic countries; however, concerns have been raised over its potential under dosing in young children. We investigated the influence of different dosing schedules on DP's clinical efficacy. METHODS AND FINDINGS: A systematic search of the literature was conducted to identify all studies published between 1960 and February 2013, in which patients were enrolled and treated with DP. Principal investigators were approached and invited to share individual patient data with the WorldWide Antimalarial Resistance Network (WWARN). Data were pooled using a standardised methodology. Univariable and multivariable risk factors for parasite recrudescence were identified using a Cox's regression model with shared frailty across the study sites. Twenty-four published and two unpublished studies (n = 7,072 patients) were included in the analysis. After correcting for reinfection by parasite genotyping, Kaplan-Meier survival estimates were 97.7% (95% CI 97.3%-98.1%) at day 42 and 97.2% (95% CI 96.7%-97.7%) at day 63. Overall 28.6% (979/3,429) of children aged 1 to 5 years received a total dose of piperaquine below 48 mg/kg (the lower limit recommended by WHO); this risk was 2.3-2.9-fold greater compared to that in the other age groups and was associated with reduced efficacy at day 63 (94.4% [95% CI 92.6%-96.2%], p<0.001). After adjusting for confounding factors, the mg/kg dose of piperaquine was found to be a significant predictor for recrudescence, the risk increasing by 13% (95% CI 5.0%-21%) for every 5 mg/kg decrease in dose; p = 0.002. In a multivariable model increasing the target minimum total dose of piperaquine in children aged 1 to 5 years old from 48 mg/kg to 59 mg/kg would halve the risk of treatment failure and cure at least 95% of patients; such an increment was not associated with gastrointestinal toxicity in the ten studies in which this could be assessed.

Published
2013

10. Pharmacokinetics, safety, and efficacy of a single co-administered dose of diethylcarbamazine, albendazole and ivermectin in adults with and without Wuchereria bancrofti infection in Côte d'Ivoire.

Author

Edi C, Bjerum CM, Ouattara AF, Chhonker YS, Penali LK, Méité A, Koudou BG, Weil GJ, King CL, and Murry DJ

Subjects
Adolescent, Adult, Aged, Albendazole adverse effects, Albendazole pharmacokinetics, Animals, Cohort Studies, Cote d'Ivoire, Diethylcarbamazine adverse effects, Diethylcarbamazine pharmacokinetics, Drug Combinations, Elephantiasis, Filarial parasitology, Female, Filaricides adverse effects, Filaricides pharmacokinetics, Humans, Ivermectin adverse effects, Ivermectin pharmacokinetics, Male, Middle Aged, Treatment Outcome, Wuchereria bancrofti physiology, Young Adult, Albendazole administration & dosage, Diethylcarbamazine administration & dosage, Elephantiasis, Filarial drug therapy, Filaricides administration & dosage, Ivermectin administration & dosage, Wuchereria bancrofti drug effects
Abstract

Background: A single co-administered dose of ivermectin (IVM) plus diethylcarbamazine (DEC) plus albendazole (ALB), or triple-drug therapy, was recently found to be more effective for clearing microfilariae (Mf) than standard DEC plus ALB currently used for mass drug administration programs for lymphatic filariasis (LF) outside of sub-Saharan Africa. Triple-drug therapy has not been previously tested in LF-uninfected individuals from Africa. This study evaluated the pharmacokinetics (PK), safety, and efficacy of triple-drug therapy in people with and without Wuchereria bancrofti infection in West Africa., Methods: In this open-label cohort study, treatment-naïve microfilaremic (>50 mf/mL, n = 32) and uninfected (circulating filarial antigen negative, n = 24) adults residing in Agboville district, Côte d'Ivoire, were treated with a single dose of IVM plus DEC plus ALB, and evaluated for adverse events (AEs) until 7 days post treatment. Drug levels were assessed by liquid chromatography and mass spectrometry. Persons responsible for assessing AEs were blinded to participants' infection status., Findings: There was no difference in AUC0-inf or Cmax between LF-infected and uninfected participants (P>0.05 for all comparisons). All subjects experienced mild AEs; 28% and 25% of infected and uninfected participants experienced grade 2 AEs, respectively. There were no severe or serious adverse events. Only fever (16 of 32 versus 4 of 24, P<0.001) and scrotal pain/swelling in males (6 of 20 versus 0 of 12, P = 0.025) were more frequent in infected than uninfected participants. All LF positive participants were amicrofilaremic at 7 days post-treatment and 27 of 31 (87%) remained amicrofilaremic 12 months after treatment., Conclusions: Moderate to heavy W. bancrofti infection did not affect PK parameters for IVM, DEC or ALB following a single co-administered dose of these drugs compared to uninfected individuals. The drugs were well tolerated. This study confirmed the efficacy of the triple-drug therapy for clearing W. bancrofti Mf and has added important information to support the use of this regimen in LF elimination programs in areas of Africa without co-endemic onchocerciasis or loiasis., Trial Registration: ClinicalTrials.gov NCT02845713., Competing Interests: The authors have declared that no competing interests exist.

Published
2019
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11. The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: a meta-analysis of individual patient data.

Author

Adjuik MA, Allan R, Anvikar AR, Ashley EA, Ba MS, Barennes H, Barnes KI, Bassat Q, Baudin E, Björkman A, Bompart F, Bonnet M, Borrmann S, Brasseur P, Bukirwa H, Checchi F, Cot M, Dahal P, D'Alessandro U, Deloron P, Desai M, Diap G, Djimde AA, Dorsey G, Doumbo OK, Espié E, Etard JF, Fanello CI, Faucher JF, Faye B, Flegg JA, Gaye O, Gething PW, González R, Grandesso F, Guerin PJ, Guthmann JP, Hamour S, Hasugian AR, Hay SI, Humphreys GS, Jullien V, Juma E, Kamya MR, Karema C, Kiechel JR, Kremsner PG, Krishna S, Lameyre V, Ibrahim LM, Lee SJ, Lell B, Mårtensson A, Massougbodji A, Menan H, Ménard D, Menéndez C, Meremikwu M, Moreira C, Nabasumba C, Nambozi M, Ndiaye JL, Nikiema F, Nsanzabana C, Ntoumi F, Ogutu BR, Olliaro P, Osorio L, Ouédraogo JB, Penali LK, Pene M, Pinoges L, Piola P, Price RN, Roper C, Rosenthal PJ, Rwagacondo CE, Same-Ekobo A, Schramm B, Seck A, Sharma B, Sibley CH, Sinou V, Sirima SB, Smith JJ, Smithuis F, Somé FA, Sow D, Staedke SG, Stepniewska K, Swarthout TD, Sylla K, Talisuna AO, Tarning J, Taylor WR, Temu EA, Thwing JI, Tjitra E, Tine RC, Tinto H, Vaillant MT, Valecha N, Van den Broek I, White NJ, Yeka A, and Zongo I

Subjects
Africa, Dose-Response Relationship, Drug, Drug Combinations, Female, Humans, Male, Middle Aged, Recurrence, Risk Factors, Treatment Outcome, Amodiaquine administration & dosage, Antimalarials administration & dosage, Artemisinins administration & dosage, Malaria, Falciparum drug therapy
Abstract

Background: Artesunate-amodiaquine (AS-AQ) is one of the most widely used artemisinin-based combination therapies (ACTs) to treat uncomplicated Plasmodium falciparum malaria in Africa. We investigated the impact of different dosing strategies on the efficacy of this combination for the treatment of falciparum malaria., Methods: Individual patient data from AS-AQ clinical trials were pooled using the WorldWide Antimalarial Resistance Network (WWARN) standardised methodology. Risk factors for treatment failure were identified using a Cox regression model with shared frailty across study sites., Results: Forty-three studies representing 9,106 treatments from 1999-2012 were included in the analysis; 4,138 (45.4%) treatments were with a fixed dose combination with an AQ target dose of 30 mg/kg (FDC), 1,293 (14.2%) with a non-fixed dose combination with an AQ target dose of 25 mg/kg (loose NFDC-25), 2,418 (26.6%) with a non-fixed dose combination with an AQ target dose of 30 mg/kg (loose NFDC-30), and the remaining 1,257 (13.8%) with a co-blistered non-fixed dose combination with an AQ target dose of 30 mg/kg (co-blistered NFDC). The median dose of AQ administered was 32.1 mg/kg [IQR: 25.9-38.2], the highest dose being administered to patients treated with co-blistered NFDC (median = 35.3 mg/kg [IQR: 30.6-43.7]) and the lowest to those treated with loose NFDC-25 (median = 25.0 mg/kg [IQR: 22.7-25.0]). Patients treated with FDC received a median dose of 32.4 mg/kg [IQR: 27-39.0]. After adjusting for reinfections, the corrected antimalarial efficacy on day 28 after treatment was similar for co-blistered NFDC (97.9% [95% confidence interval (CI): 97.0-98.8%]) and FDC (98.1% [95% CI: 97.6%-98.5%]; P = 0.799), but significantly lower for the loose NFDC-25 (93.4% [95% CI: 91.9%-94.9%]), and loose NFDC-30 (95.0% [95% CI: 94.1%-95.9%]) (P < 0.001 for all comparisons). After controlling for age, AQ dose, baseline parasitemia and region; treatment with loose NFDC-25 was associated with a 3.5-fold greater risk of recrudescence by day 28 (adjusted hazard ratio, AHR = 3.51 [95% CI: 2.02-6.12], P < 0.001) compared to FDC, and treatment with loose NFDC-30 was associated with a higher risk of recrudescence at only three sites., Conclusions: There was substantial variation in the total dose of amodiaquine administered in different AS-AQ combination regimens. Fixed dose AS-AQ combinations ensure optimal dosing and provide higher antimalarial treatment efficacy than the loose individual tablets in all age categories.

Published
2015
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12. Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study.

Author

Chandra R, Ansah P, Sagara I, Sie A, Tiono AB, Djimde AA, Zhao Q, Robbins J, Penali LK, and Ogutu B

Subjects
Africa South of the Sahara epidemiology, Antimalarials adverse effects, Antimalarials blood, Antimalarials pharmacokinetics, Artemether, Lumefantrine Drug Combination, Artemisinins adverse effects, Artemisinins blood, Artemisinins pharmacokinetics, Azithromycin adverse effects, Azithromycin blood, Azithromycin pharmacokinetics, Child, Child, Preschool, Chloroquine adverse effects, Chloroquine blood, Chloroquine pharmacokinetics, Drug Combinations, Ethanolamines adverse effects, Ethanolamines blood, Ethanolamines pharmacokinetics, Female, Fluorenes adverse effects, Fluorenes blood, Fluorenes pharmacokinetics, Humans, Infant, Male, Antimalarials therapeutic use, Artemisinins therapeutic use, Azithromycin therapeutic use, Chloroquine therapeutic use, Ethanolamines therapeutic use, Fluorenes therapeutic use, Malaria, Falciparum drug therapy, Malaria, Falciparum epidemiology
Abstract

Background: This randomized, open-label study was conducted to establish the non-inferiority of a combination of azithromycin (AZ) and chloroquine (CQ) to artemether-lumefantrine (AL) for treatment of uncomplicated malaria in children from six sites in sub-Saharan Africa., Methods: Children with uncomplicated Plasmodium falciparum malaria between six and 59 months of age were randomized 1:1 to either AZCQ (30 mg/kg AZ + 10 mg/kg CQ base) or AL per prescribing information for three days (Days 0, 1, 2). Each site could enrol in the study population once the treatment of uncomplicated malaria in five children five to 12 years of age was deemed to be effective and well tolerated. The primary efficacy evaluation was the proportion of subjects in both the modified intent-to-treat (MITT) and per-protocol (PP) populations with an adequate clinical and parasitological response (PCR corrected) at Day 28. Non-inferiority was concluded if the lower bound of the 95% confidence interval comparing the two groups was 10 percentage points or greater., Results: A total of 255 children were enrolled in the efficacy analysis (AZCQ, n = 124; AL, n = 131). The PCR corrected clearance rates were 89% (AZCQ) versus 98% (AL) for MITT, a difference of -9.10 (95% confidence interval; -16.02, -2.18) and 93% (AZCQ) versus 99% (AL) for PP, a difference of -6.08 (-12.10, -0.05). Early and late treatment failures were more common in subjects receiving AZCQ. Adverse events were more common in subjects treated with AZCQ. Drug concentrations obtained at specified time points following AZCQ administration had a large coefficient of variation partially due to sparse sampling with sample collection time window., Conclusions: In this study, non-inferiority of AZCQ to AL was not demonstrated., Trial Registration: ClinicalTrials.gov NCT00677833 .

Published
2015
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13. A comparative, randomized clinical trial of artemisinin/naphtoquine twice daily one day versus artemether/lumefantrine six doses regimen in children and adults with uncomplicated falciparum malaria in Côte d'Ivoire.

Author

Toure OA, Penali LK, Yapi JD, Ako BA, Toure W, Djerea K, Gomez GO, and Makaila O

Subjects
Adult, Artemether, Lumefantrine Drug Combination, Child, Cote d'Ivoire, Drug Administration Schedule, Drug Combinations, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Malaria, Falciparum parasitology, Male, Plasmodium falciparum isolation & purification, Polymerase Chain Reaction, Recurrence, Treatment Outcome, Antimalarials administration & dosage, Artemisinins administration & dosage, Ethanolamines administration & dosage, Fluorenes administration & dosage, Malaria, Falciparum drug therapy, Plasmodium falciparum drug effects
Abstract

Background: Drug resistance in Plasmodium falciparum poses a major threat to malaria control. Combination anti-malarial therapy, including artemisinins, has been advocated to improve efficacy and limit the spread of resistance. The fixed combination of oral artemether-lumefantrine (AL) is highly effective and well-tolerated. Artemisinin/naphtoquine (AN) is a fixed-dose ACT that has recently become available in Africa. The objectives of the study were to compare the efficacy and safety of AN and AL for the treatment of uncomplicated falciparum malaria in a high transmission-intensity site in Ivory Coast., Methods: We enrolled 122 participants aged 6 months or more with uncomplicated falciparum malaria. Participants were randomized to receive either artemisinin/naphtoquine or artemether/lumefantrine with variable dose according to their weight. Primary endpoints were the risks of treatment failure within 28 days, either unadjusted or adjusted by genotyping to distinguish recrudescence from new infection., Results: Among 125 participants enrolled, 123 (98.4%) completed follow-up. Clinical evaluation of the 123 participants showed that cumulative PCR-uncorrected cure rate on day 28 was 100% for artemisinin/naphtoquine and 98.4% for artemether/lumefantrine. Both artemisinin-based combinations effected rapid fever and parasite clearance., Interpretation: These data suggest that Arco could prove to be suitable for use as combination antimalarial therapy. Meanwhile, pharmacokinetic studies and further efficacy assessment should be conducted before its widespread use can be supported.

Published
2009
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14. Single-day, three-dose treatment with fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine to cure Plasmodium falciparum malaria.

Author

Penali LK and Jansen FH

Subjects
Child, Cote d'Ivoire, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Male, Antimalarials administration & dosage, Artemisinins administration & dosage, Malaria, Falciparum drug therapy, Pyrimethamine administration & dosage, Succinates administration & dosage, Sulfalene administration & dosage
Abstract

Objectives: Malaria kills approximately 1.5 to 2.7 million people each year. Despite the introduction of artemisinin-based combination therapies (ACTs), the treatment of malaria is hampered by problems such as inadequate efficacy, recrudescence, early re-infection, low patient compliance, and high cost price of drugs. This study tested the hypothesis that the co-formulated fixed dose combination (FDC) artesunate/sulfamethoxypyrazine/pyrimethamine (As/SMP) administered as a 24-hour therapy with a dose interval of 12 hours is as efficacious and safe as the administration of the same drug over 3 days given with a dose interval of 24 hours, for the treatment of uncomplicated Plasmodium falciparum malaria in Ivory Coast., Method: Two hundred and twenty-one patients presenting with uncomplicated P. falciparum malaria were randomly assigned to either one of the two dosing schemes. Treatment efficacy was assessed using the current 28-day World Health Organization protocol, success being determined by absence of recrudescence and parasitemia on day 28., Results: Both treatment regimens were highly efficacious, with a success rate of 100% (111/111) for the 3-day therapy and 99% (109/110) for the 24-hour therapy. Only one patient in the 24-hour therapy group showed late treatment failure. No serious adverse events or significant laboratory abnormalities were seen., Conclusion: The 24-hour therapy is as well tolerated and efficacious as the same medicament administered over 3 days. This low cost and simplified three-pill treatment is certain to improve compliance.

Published
2008
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15. Assessment of the relative advantage of various artesunate-based combination therapies by a multi-treatment Bayesian random-effects meta-analysis.

Author

Jansen FH, Lesaffre E, Penali LK, Zattera MJ, Die-Kakou H, and Bissagnene E

Subjects
Artemether, Lumefantrine Drug Combination, Artesunate, Bayes Theorem, Chloroquine therapeutic use, Drug Combinations, Drug Therapy, Combination, Ethanolamines therapeutic use, Fluorenes therapeutic use, Humans, Mefloquine therapeutic use, Pyrimethamine therapeutic use, Randomized Controlled Trials as Topic, Sulfadoxine therapeutic use, Treatment Outcome, Antimalarials therapeutic use, Artemisinins therapeutic use, Malaria drug therapy, Sesquiterpenes therapeutic use
Abstract

Over the years, multiple articles on Artemisinin-based Combination Therapies (ACTs) were published, highlighting the relative advantages or drawbacks of these combinations. Many studies were comparative. Because none of the studies compare all combinations and methodology varies between studies, there is no homogeneity. A multi-treatment Bayesian random-effects meta-analysis was designed to assess the relative effect of each combination therapy to artesunate + sulfadoxine-pyrimethamine (4 mg/kg/day for 3 days). By far the most attractive result for the variable adequate clinical and parasitological response at day 28 PCR corrected is given by the combination artemether-lumefantrine. Annual follow-up on the data published is intended to reveal the changes in the relative drug efficacy values of ACTs.

Published
2007

16. [Therapeutic efficacy of chloroquine in the uncomplicated malaria due to Plasmodium falciparum in hospital patients in central Ivory Coast (1997-2000)].

Author

Adou-Bryn KD, Krelo K, Akoussi CF, Boni NM, Yapo GC, Penali LK, Ouhon J, Assoumou A, and Ehouman A

Subjects
Age Factors, Child, Preschool, Cote d'Ivoire epidemiology, Drug Administration Schedule, Hospitalization, Humans, Infant, Malaria, Falciparum epidemiology, Parasitic Sensitivity Tests, Patient Selection, Population Surveillance, Severity of Illness Index, Treatment Outcome, Antimalarials therapeutic use, Chloroquine therapeutic use, Malaria, Falciparum drug therapy, Malaria, Falciparum parasitology
Abstract

A study in vivo of Plasmodium falciparum sensitivity to chloroquine was carried out from April 1997 to February 2000 at Yamoussoukro, Kossou and Bouaké in the central region of Côte d'Ivoire. This study was included in the national Plasmodium falciparum-sensitivity program. One hundred and sixteen subjects consulting for suspected malaria were included according to the WHO's standard of 14 days. Chloroquine was administered on a dosage of 25 mg/kg, spread over three days. Among 108 subjects who finished the treatment, 26.9% (29/108) had therapeutic failure to chloroquine (23 precocious therapeutic failure and 6 late therapeutic failure). Chloroquine was more efficacious in Yamoussoukro (87.5% of clinical appropriate response) and Bouaké (82.5%) than in Kossou (61.7%). Parasitic reduction on subjects with therapeutic failure was higher than 85%. The risk of therapeutic failure is not linked to age of patient. Before a revaluation of this situation, chloroquine should always be recommended as a first-line treatment for uncomplicated malaria for the local populations.

Published
2002

17. [Parasitological and clinical response to amodiaquine versus chloroquine in the treatment of Plasmodium falciparum malaria in children in an endemic area].

Author

Penali LK, Assi-Coulibaly L, Kaptué B, Konan D, and Ehouman A

Subjects
Adolescent, Amodiaquine adverse effects, Child, Child, Preschool, Chloroquine adverse effects, Drug Resistance, Female, Humans, Infant, Male, Amodiaquine therapeutic use, Chloroquine therapeutic use, Malaria, Falciparum drug therapy
Abstract

The therapeutic management of malaria in endemic regions is now hampered not only by the limited number of antimalarial agents, but also by the appearance of chemoresistant plasmodial strains and by the sometimes severe adverse effects related to the use of some of these drugs. Between January and July 1993, 100 patients presenting with symptomatic Plasmodium falciparum malaria were randomised to receive amodiaquine or chloroquine at the dose of 30 mg/kg for 3 days. The objective of this study was to compare the efficacy and safety of these two 4-aminoquinolines in the treatment of uncomplicated malaria. The parasite clearance was 4.87 (+/- 0.33) days in the amodiaquine group and 5.55 (+/- 0.31) days in the chloroquine group. All subjects in both groups were afebrile by D7. Cutaneous adverse effects, such as pruritus, were reported with both amodiaquine (3.2%) and chloroquine (6.8%). Amodiaquine was found to be significantly more effective than chloroquine in terms of parasite clearance on D7. The therapeutic failure rate was 0% for amodiaquine versus 16.3% for chloroquine. At a time when chemoresistance of Plasmodium falciparum, especially chloroquine-resistance, has spread to malarial endemic zones, amodiaquine should be very widely indicated in the treatment of simple malaria due to its excellent efficacy and good safety.

Published
1994

18. [Decrease in chloroquine resistant Plasmodium falciparum in the Abidjan region (Ivory Coast)].

Author

Penali LK, Kone M, Komenan A, and Coulibaly L

Subjects
Body Temperature, Body Weight, Child, Preschool, Chloroquine administration & dosage, Chloroquine therapeutic use, Clinical Protocols, Drug Administration Schedule, Drug Resistance, Fever diagnosis, Fever etiology, Humans, Infant, Malaria, Falciparum complications, Malaria, Falciparum parasitology, Malaria, Falciparum drug therapy, Malaria, Falciparum epidemiology, Population Surveillance
Abstract

The authors reviewed the evolution of Plasmodium falciparum chloroquine resistance in greater Abidjan for the year 1990. They used the classical course of treatment consisting of 25 mg per kg of bodyweight distributed on three days. Parasitaemia and body temperature controls were carried out on day O, day 2 and day 7. The study, which involved 547 children averaging 38.3 months of age disclosed an early in vivo resistance in the range of 18.20% as against 29.6% in 1988.

Published
1993

19. [Cryptosporidiosis and HIV in Abidjan (Ivory Coast)].

Author

Assoumou A, Kone M, Penali LK, Coulibaly M, and N'Draman AA

Subjects
Acquired Immunodeficiency Syndrome complications, Acquired Immunodeficiency Syndrome epidemiology, Adult, Cote d'Ivoire epidemiology, Cryptosporidiosis diagnosis, Cryptosporidiosis epidemiology, HIV Infections epidemiology, Humans, Cryptosporidiosis complications, HIV Infections complications
Abstract

A coprological study realized with 217 HIV adult subjects has allowed to evaluate the frequency of the cryptosporidiosis during this affection in Abidjan. Cryptosporidium sp. has been found in 8.7% of the subjects. Otherwise 78.9% of the patients had a chronic diarrhoea. 89.4% showed an abdominal pain and were dehydrated 94.7% had lost weight and 21% had nausea or vomiting.

Published
1993

20. [Cryptosporidiosis in Ivorian children form Yopougon].

Author

Kone M, Penali LK, Enoh S, Gershy-Damet GM, and Anderson M

Subjects
Cote d'Ivoire epidemiology, Cryptosporidiosis diagnosis, Humans, Infant, Cryptosporidiosis epidemiology
Abstract

Coprological survey involving 250 ivorian children with diarrhoea was done to evaluate the incidence of cryptosporidiosis. Crypstosporidium sp. was found in 10.4% of subjects. 76.9, 57.7 and 19.2% Cryptosporidium positive children had profuse diarrhoea, fever and pulmonary symptoms respectively. In Ivory Coast, children diarrhoeas due to cryptosporidiosis are quantitatively important.

Published
1992

21. [In-vivo evaluation of Plasmodium falciparum sensitivity to chloroquine in Abidjan].

Author

Kone M, Penali LK, Houdier M, Assoumou A, and Coulibaly A

Subjects
Animals, Child, Child, Preschool, Chloroquine pharmacology, Cote d'Ivoire epidemiology, Female, Humans, Malaria epidemiology, Male, Microbial Sensitivity Tests, Chloroquine therapeutic use, Malaria drug therapy, Plasmodium falciparum drug effects
Abstract

In vivo tests of Plasmodium falciparum chloroquine sensitivity were conducted in October and November, 1988 with 81 children aged 5 to 9 in several districts of Abidjan, Ivory Coast. The WHO standard scheme covering 7 days on basis of 25 mg per kilo spread over 3 days resulted in a therapeutic failure in 29.6 per cent cases. Nevertheless, a drop in overall parasitemia by over 80 per cent was noted from Day-0 to Day-2 in 70 per cent of visible resistance. Only in vivo tests conducted at a later stage with identification of chloroquine in the blood stream, with together in vitro studies will make it possible to know the actual level of resistance of Plasmodium falciparum strains to chloroquine.

Published
1990

22. [Parasites of fish currently consumed in the Ivory Coast].

Author

Penali LK, Gershy-Damet GM, Sangare A, Ouattara SA, Cisse A, Faye H, Dosso M, Assale NG, and Adjetey AK

Subjects
Acanthocephala isolation & purification, Animals, Ascaris isolation & purification, Cote d'Ivoire, Fasciola isolation & purification, Necator isolation & purification, Paragonimus isolation & purification, Fishes parasitology
Abstract

The authors study parasites of the six most commonly consumed species of fishes in Côte-d'Ivoire. Analysis of gills, alimentary canal and blood of 188 fishes reveal the presence of extremely diverse families of parasites.

Published
1988

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