Search

Your search keyword '"Espie, E"' showing total 25 results
Start Over Author "Espie, E" Search Limiters Full Text
25 results on '"Espie, E"'

4. Temporal distribution of Plasmodium falciparum recrudescence following artemisinin-based combination therapy: an individual participant data meta-analysis

Author

Dahal, P, Simpson, JA, Abdulla, S, Achan, J, Adam, I, Agarwal, A, Allan, R, Anvikar, AR, Ashley, EA, Bassat, Q, Borrmann, S, Bousema, T, Bukirwa, H, Carrara, V, Corsi, M, D'Alessandro, U, Davis, TME, Deloron, P, Desai, M, Dimbu, PR, Djalle, D, Djimde, A, Dorsey, G, Drakeley, CJ, Duparc, S, Edstein, MD, Espie, E, Abul, F, Falade, C, Fanello, C, Faucher, J-F, Faye, B, Fortes, FDJ, Gadalla, NB, Gaye, O, Gil, JP, Gilayeneh, J, Greenwood, B, Grivoyannis, A, Hien, TT, Hwang, J, Janssens, B, Juma, E, Kamugisha, E, Karema, C, Karunajeewa, HA, Kiechel, JR, Kironde, F, Kofoed, P-E, Kremsner, PG, Lee, SJ, Marsh, K, Martensson, A, Mayxay, M, Menan, H, Mens, P, Mutabingwa, TK, Ndiaye, J-L, Ngasala, BE, Noedl, H, Nosten, F, Offianan, AT, Ogutu, BR, Olliaro, PL, Ouedraogo, JB, Piola, P, Plowe, C, Plucinski, MM, Pratt, OJ, Premji, Z, Ramharter, M, Rogier, C, Vitare, P, Rombo, L, Rosenthal, PJ, Sibley, C, Sirima, S, Smithuis, F, Staedke, SG, Sutanto, I, Talisuna, AO, Tarning, J, Taylor, WRJ, Temu, E, Thriemer, K, Thuy-Nhien, N, Udhayakumar, V, Ursing, JD, van Herp, M, van Lenthe, M, van Vugt, M, William, Y, Winnips, C, Zaloumis, S, Zongo, I, White, NJ, Guerin, PJ, Stepniewska, K, Price, RN, Arinaitwe, E, Dahal, P, Simpson, JA, Abdulla, S, Achan, J, Adam, I, Agarwal, A, Allan, R, Anvikar, AR, Ashley, EA, Bassat, Q, Borrmann, S, Bousema, T, Bukirwa, H, Carrara, V, Corsi, M, D'Alessandro, U, Davis, TME, Deloron, P, Desai, M, Dimbu, PR, Djalle, D, Djimde, A, Dorsey, G, Drakeley, CJ, Duparc, S, Edstein, MD, Espie, E, Abul, F, Falade, C, Fanello, C, Faucher, J-F, Faye, B, Fortes, FDJ, Gadalla, NB, Gaye, O, Gil, JP, Gilayeneh, J, Greenwood, B, Grivoyannis, A, Hien, TT, Hwang, J, Janssens, B, Juma, E, Kamugisha, E, Karema, C, Karunajeewa, HA, Kiechel, JR, Kironde, F, Kofoed, P-E, Kremsner, PG, Lee, SJ, Marsh, K, Martensson, A, Mayxay, M, Menan, H, Mens, P, Mutabingwa, TK, Ndiaye, J-L, Ngasala, BE, Noedl, H, Nosten, F, Offianan, AT, Ogutu, BR, Olliaro, PL, Ouedraogo, JB, Piola, P, Plowe, C, Plucinski, MM, Pratt, OJ, Premji, Z, Ramharter, M, Rogier, C, Vitare, P, Rombo, L, Rosenthal, PJ, Sibley, C, Sirima, S, Smithuis, F, Staedke, SG, Sutanto, I, Talisuna, AO, Tarning, J, Taylor, WRJ, Temu, E, Thriemer, K, Thuy-Nhien, N, Udhayakumar, V, Ursing, JD, van Herp, M, van Lenthe, M, van Vugt, M, William, Y, Winnips, C, Zaloumis, S, Zongo, I, White, NJ, Guerin, PJ, Stepniewska, K, Price, RN, and Arinaitwe, E

Abstract

BACKGROUND: The duration of trial follow-up affects the ability to detect recrudescent infections following anti-malarial treatment. The aim of this study was to explore the proportions of recrudescent parasitaemia as ascribed by genotyping captured at various follow-up time-points in treatment efficacy trials for uncomplicated Plasmodium falciparum malaria. METHODS: Individual patient data from 83 anti-malarial efficacy studies collated in the WorldWide Antimalarial Resistance Network (WWARN) repository with at least 28 days follow-up were available. The temporal and cumulative distributions of recrudescence were characterized using a Cox regression model with shared frailty on study-sites. Fractional polynomials were used to capture non-linear instantaneous hazard. The area under the density curve (AUC) of the constructed distribution was used to estimate the optimal follow-up period for capturing a P. falciparum malaria recrudescence. Simulation studies were conducted based on the constructed distributions to quantify the absolute overestimation in efficacy due to sub-optimal follow-up. RESULTS: Overall, 3703 recurrent infections were detected in 60 studies conducted in Africa (15,512 children aged < 5 years) and 23 studies conducted in Asia and South America (5272 patients of all ages). Using molecular genotyping, 519 (14.0%) recurrences were ascribed as recrudescent infections. A 28 day artemether-lumefantrine (AL) efficacy trial would not have detected 58% [95% confidence interval (CI) 47-74%] of recrudescences in African children and 32% [95% CI 15-45%] in patients of all ages in Asia/South America. The corresponding estimate following a 42 day dihydroartemisinin-piperaquine (DP) efficacy trial in Africa was 47% [95% CI 19-90%] in children under 5 years old treated with > 48 mg/kg total piperaquine (PIP) dose and 9% [95% CI 0-22%] in those treated with ≤ 48 mg/kg PIP dose. In absolute terms, the simulation study found that trials limited to 28 days follow-up

Published
2022

5. 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

9. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Author

Lopez-Fauqued, M, Campora, L, Delannois, F, El Idrissi, M, Oostvogels, L, De Looze, F, Diez-Domingo, J, Heineman, T, Lal, H, McElhaney, J, McNeil, S, Yeo, W, Tavares-Da-Silva, F, Ahonen, A, Avelino-Silva, T, Barba-Gomez, J, Berglund, J, Cuixart, C, Caso, C, Chlibek, R, Choi, W, Cunningham, A, Desole, M, Eizenberg, P, Esen, M, Espie, E, Gervais, P, Ghesquiere, W, Godeaux, O, Gorfinkel, I, Hui, D, Hwang, S, Korhonen, T, Kovac, M, Ledent, E, Leung, E, Levin, M, Perez, S, Neto, J, Pauksens, K, Poder, A, de la Pinta, M, Rombo, L, Schwarz, T, Smetana, J, Staniscia, T, Tinoco, J, Toma, A, Vastiau, I, Vesikari, T, Volpi, A, Watanabe, D, Weckx, L, Zahaf, T, and ZOE-Study Grp

Subjects
Reactogenicity, Varicella-zoster virus, Safety, Vaccine
Abstract

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was >= 90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged >= 50 (ZOE-50) and >= 70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. (C) 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.

Published
2019

13. 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, G, Adjuik, M, Alemayehu, B, Allan, R, Arinaitwe, E, Ashley, E, Ba, MS, Barennes, H, Barnes, K, 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, A, Dorsey, G, Doumbo, O, Drakeley, C, Duparc, S, Eshetu, T, Espie, E, Etard, J, Faiz, A, Falade, C, Fanello, C, Faucher, J, Faye, B, Faye, O, Filler, S, Flegg, J, Fofana, B, Fogg, C, Gadalla, N, Gaye, O, Genton, B, Gething, P, Gil, J, Gonzalez, R, Grandesso, F, Greenhouse, B, Greenwood, B, Grivoyannis, A, Guerin, P, Guthmann, J, Hamed, K, Hamour, S, Hay, S, Hodel, E, Humphreys, G, Hwang, J, Ibrahim, M, Jima, D, Jones, J, Jullien, V, Juma, E, Kachur, P, Kager, P, Kamugisha, E, Kamya, MR, Karema, C, Kayentao, K, Kiechel, J, Kironde, F, Kofoed, P, Kremsner, P, Krishna, S, Lameyre, V, Lell, B, Lima, A, Makanga, M, Malik, E, Marsh, K, Martensson, A, Massougbodji, A, Menan, H, Menard, D, Menendez, C, Mens, P, Meremikwu, M, Moreira, C, Nabasumba, C, Nambozi, M, Ndiaye, J, Ngasala, B, Nikiema, F, Nsanzabana, C, Ntoumi, F, Oguike, M, Ogutu, B, Olliaro, P, Omar, SA, Ouedraogo, J, Owusu-Agyei, S, Penali, L, Pene, M, Peshu, J, Piola, P, Plowe, C, Premji, Z, Price, R, Randrianarivelojosia, M, Rombo, L, Roper, C, Rosenthal, P, Sagara, I, Same-Ekobo, A, Sawa, P, Schallig, H, Schramm, B, Seck, A, Shekalaghe, SA, Sibley, C, Sinou, V, Sirima, S, Som, F, Sow, D, Staedke, S, Stepniewska, K, Sutherland, C, Swarthout, T, Sylla, K, Talisuna, A, Taylor, W, Temu, E, Thwing, J, Tine, R, Tinto, H, Tommasini, S, Toure, O, Ursing, J, Vaillant, M, Valentini, G, Van den Broek, I, Van Vugt, M, Ward, SA, Winstanley, P, Yavo, W, Yeka, A, Zolia, Y, Zongo, I, Based, W, Unité de Recherche sur le Paludisme [Antananarivo, Madagascar], Institut Pasteur de Madagascar, and Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)

Subjects
Male, Infektionsmedicin, Antimalarial, MESH: Africa, law.invention, Amodiaquine/therapeutic use, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, law, 030212 general & internal medicine, Artemether, Prospective Studies, Malaria, Falciparum, Prospective cohort study, MESH: Plasmodium falciparum, Medicine(all), MESH: Middle Aged, MESH: Malaria, Falciparum, Malaria, Falciparum/drug therapy, General Medicine, Middle Aged, MESH: Infant, Artemisinins, 3. Good health, Drug Combinations, Meta-analysis, parasite, Quinolines, Drug Therapy, Combination, Artemisinin based Combination Therapy (ACT), MESH: Quinolines, medicine.drug, Falciparum, Infectious Medicine, medicine.medical_specialty, 030231 tropical medicine, Plasmodium falciparum, ARTEMISININ-RESISTANT MALARIA PLASMODIUM-FALCIPARUM PARASITE CLEARANCE ARTEMETHER-LUMEFANTRINE COMBINATION THERAPY IN-VIVO EFFICACY ARTESUNATE CHILDREN PHARMACOKINETICS, Quinolines/administration & dosage, African patients, 03 medical and health sciences, Antimalarials, Internal medicine, MESH: Artemisinins, parasitic diseases, Artemisinin combination therapy, medicine, Humans, MESH: Africa South of the Sahara, Falciparum malaria, Risk factor, MESH: Amodiaquine, Africa South of the Sahara, Parasite clearance, MESH: Drug Combinations, MESH: Humans, business.industry, Amodiaquine, Infant, Odds ratio, MESH: Antimalarials, MESH: Male, MESH: Prospective Studies, Surgery, Malaria, Clinical trial, Artemisinins/administration & dosage, MESH: Drug Therapy, Combination, chemistry, Artesunate, Africa, Commentary, Antimalarials/administration & dosage, business
Abstract

WWARN Artemisinin based Combination Therapy (ACT) Africa Baseline Study Group; International audience; 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 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: 1.38–5.36), P = 0.004); and treatment with the loose formulation of artesunate-amodiaquine (AOR = 2.27 (95 % CI: 1.14–4.51), P = 0.020, compared to dihydroartemisinin-piperaquine). Conclusions: The three ACTs assessed in this analysis continue to achieve rapid early parasitological clearance across the sites assessed in Sub-Saharan Africa. A threshold of 5 % day 3 parasite positivity from a minimum sample size of 50 patients provides a more sensitive benchmark in Sub-Saharan Africa compared to the current recommended threshold of 10 % to trigger further investigation of artemisinin susceptibility.

Published
2015
Full Text
View/download PDF

14. 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

15. 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, G. O., Adjuik, M. A., Alemayehu, B., Allan, R., Arinaitwe, E., Ashley, E. A., Ba, M. S., Barennes, H., Barnes, K. I., Bassat, Q., Baudin, E., Berens-Riha, N., Bjorkman, A., Bompart, F., Bonnet, M., Borrmann, S., Bousema, T., Brasseur, Philippe, Bukirwa, H., Checchi, F., Dahal, P., D'Alessandro, U., Desai, M., Dicko, A., Djimde, A. A., Dorsey, G., Doumbo, O. K., Drakeley, C. J., Duparc, S., Eshetu, T., Espie, E., and Etard, Jean-François

Subjects
parasitic diseases
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 37.5 degrees 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: 1.38-5.36), P = 0.004); and treatment with the loose formulation of artesunate-amodiaquine (AOR = 2.27 (95 % CI: 1.14-4.51), P = 0.020, compared to dihydroartemisinin-piperaquine). Conclusions: The three ACTs assessed in this analysis continue to achieve rapid early parasitological clearance across the sites assessed in Sub-Saharan Africa. A threshold of 5 % day 3 parasite positivity from a minimum sample size of 50 patients provides a more sensitive benchmark in Sub-Saharan Africa compared to the current recommended threshold of 10 % to trigger further investigation of artemisinin susceptibility.

Published
2015

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

Author

Anstey, N. M., Price, R. N., Davis, T. M. E., Karunajeewa, H. A., Mueller, I., D'Alessandro, U., Massougbodji, A., Nikiema, F., Ouedraogo, J. B., Tinto, H., Zongo, I., Same-Ekobo, A., Kone, M., Menan, H., Toure, A. O., Yavo, W., Kofoed, P. E., Alemayehu, B. H., Jima, D., Baudin, E., Espie, E., Nabasumba, C., Pinoges, L., Schramm, B., Cot, Michel, and Deloron, Philippe

Subjects
parasitic diseases
Abstract

Background Artemether-lumefantrine is the most widely used artemisinin-based combination therapy for malaria, although treatment failures occur in some regions. We investigated the effect of dosing strategy on efficacy in a pooled analysis from trials done in a wide range of malaria-endemic settings. Methods We searched PubMed for clinical trials that enrolled and treated patients with artemether-lumefantrine and were published from 1960 to December, 2012. We merged individual patient data from these trials by use of standardised methods. The primary endpoint was the PCR-adjusted risk of Plasmodium falciparum recrudescence by day 28. Secondary endpoints consisted of the PCR-adjusted risk of P falciparum recurrence by day 42, PCR-unadjusted risk of P falciparum recurrence by day 42, early parasite clearance, and gametocyte carriage. Risk factors for PCR-adjusted recrudescence were identified using Cox's regression model with frailty shared across the study sites. Findings We included 61 studies done between January, 1998, and December, 2012, and included 14 327 patients in our analyses. The PCR-adjusted therapeutic efficacy was 97.6% (95% CI 97.4-97.9) at day 28 and 96.0% (95.6-96.5) at day 42. After controlling for age and parasitaemia, patients prescribed a higher dose of artemether had a lower risk of having parasitaemia on day 1 (adjusted odds ratio [OR] 0.92, 95% CI 0.86-0.99 for every 1 mg/kg increase in daily artemether dose; p=0.024), but not on day 2 (p=0.69) or day 3 (0.087). In Asia, children weighing 10-15 kg who received a total lumefantrine dose less than 60 mg/kg had the lowest PCR-adjusted efficacy (91.7%, 95% CI 86.5-96.9). In Africa, the risk of treatment failure was greatest in malnourished children aged 1-3 years (PCR-adjusted efficacy 94.3%, 95% CI 92.3-96.3). A higher artemether dose was associated with a lower gametocyte presence within 14 days of treatment (adjusted OR 0.92, 95% CI 0.85-0.99; p=0.037 for every 1 mg/kg increase in total artemether dose). Interpretation The recommended dose of artemether-lumefantrine provides reliable efficacy in most patients with uncomplicated malaria. However, therapeutic efficacy was lowest in young children from Asia and young underweight children from Africa; a higher dose regimen should be assessed in these groups.

Published
2015

17. 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

23. Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group.

Author

Chandler RE, Balakrishnan MR, Brasseur D, Bryan P, Espie E, Hartmann K, Jouquelet-Royer C, Milligan J, Nesbitt L, Pal S, Precioso A, Takey P, and Chen RT

Subjects
Humans, Pandemics prevention & control, Ecosystem, Pharmacovigilance, COVID-19 prevention & control, Vaccines adverse effects
Abstract

This analysis describes the successes, challenges and opportunities to improve global vaccine safety surveillance as observed by the Vaccine Safety Working Group from its role as a platform of exchange for stakeholders responsible for monitoring the safety of vaccines distributed through the COVAX mechanism. Three key elements considered to be essential for ongoing and future pandemic preparedness for vaccine developers in their interaction with other members of the vaccine safety ecosystem are (1) the availability of infrastructure and capacity for active vaccine safety surveillance in low-income and middle-income countries (LMICs), including the advancement of concepts of safety surveillance and risk management to vaccine developers and manufacturers from LMICs; (2) more comprehensive mechanisms to ensure timely exchange of vaccine safety data and/or knowledge gaps between public health authorities and vaccine developers and manufacturers; and (3) further implementation of the concept of regulatory reliance in pharmacovigilance. These aims would both conserve valuable resources and allow for more equitable access to vaccine safety information and for benefit/risk decision-making., Competing Interests: Competing interests: None declared., (© World Health Organization 2024. Licensee BMJ.)

Published
2024
Full Text
View/download PDF

24. Burden of herpes zoster in 16 selected immunocompromised populations in England: a cohort study in the Clinical Practice Research Datalink 2000-2012.

Author

Yanni EA, Ferreira G, Guennec M, El Hahi Y, El Ghachi A, Haguinet F, Espie E, and Bianco V

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Databases, Factual, England epidemiology, Female, Humans, Incidence, Male, Middle Aged, Multivariate Analysis, Neuralgia, Postherpetic epidemiology, Regression Analysis, Retrospective Studies, Risk Factors, Young Adult, Cost of Illness, Herpes Zoster epidemiology, Immunocompromised Host
Abstract

Objectives: Herpes zoster (HZ) is caused by reactivation of varicella-zoster virus which remains latent in individuals after a varicella infection. It is expected that HZ will be more frequent in immunocompromised (IC) individuals than in immunocompetent (IC-free). This study assessed the incidence rate (IR) of HZ in individuals with a wide set of IC conditions and in IC-free individuals., Setting: A retrospective cohort study was conducted in England using data (January 2000 to March 2012) from the Clinical Practice Research Datalink with linkage to the Hospital Episodes Statistics., Participants: A cohort of 621 588 individuals with 16 selected IC conditions and a gender/age-matched cohort of IC-free individuals were identified. The IC conditions included haematopoietic stem cell transplant (HSCT), solid organ transplant, malignancies, autoimmune diseases and users of immunosuppressive medications., Outcomes: IR of HZ per 1000 person-years (PY) was estimated. Proportions of postherpetic neuralgia (PHN) and other HZ complications within 90 days of HZ onset were also estimated among patients with HZ. Risk factors for PHN in IC individuals with HZ were assessed by a multivariate regression model., Results: The overall IR of HZ in the IC cohort was 7.8/1000 PY (95% CI 7.7 to 7.9), increasing with age from 3.5/1000 PY (3.4-3.7) in individuals aged 18-49 years to 12.6/1000 PY (12.2-13.0) in individuals aged ≥80 years. This IR in the IC-free cohort was 6.2/1000 PY (6.1-6.3). The overall IR of HZ varied across IC conditions, ranging from 5.3 (5.1-5.5) in psoriasis to 41.7/1000 PY (35.7-48.4) in HSCT. The proportions of PHN and other HZ complications were 10.7% (10.2-11.1) and 2.9% (2.7-3.2) in the IC cohort, but 9.1% (8.7-9.5) and 2.3% (2.1-2.6) in the IC-free cohort, respectively., Conclusion: IC population contributes to the public health burden of HZ in England. Vaccination might be the most preferable HZ preventive measure for the IC population., Competing Interests: Competing interests: VB, FH, EE and EAY are employees of the GSK group of companies. AEG, YEH and MG have nothing to disclose. GF was employed by the GSK group of companies between 2012 and February 2015, during which the study was designed and implemented. Later, as an employee of P-95 Epidemiology and Pharmacovigilance, GF provided contracted consultancy services to the GSK group of companies for this and other GSK-sponsored studies. P-95 provides contracted services to the GSK group of companies beyond the scope of this study., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2018
Full Text
View/download PDF

25. Perspectives on epilepsy in people with intellectual disabilities: comparison of family carer, staff carer and clinician score profiles on the Glasgow Epilepsy Outcome Scale (GEOS).

Author

Espie CA, Watkins J, Duncan R, Sterrick M, McDonach E, Espie E, and McGarvey C

Subjects
Adult, Attitude of Health Personnel, Attitude to Health, Female, Glasgow Outcome Scale, Humans, Male, Middle Aged, Reproducibility of Results, Caregivers psychology, Cognition Disorders, Epilepsy, Family psychology, Health Personnel psychology
Abstract

Purpose: Clinical practice with people with intellectual disability relies heavily upon caregiver report. Crucially, the carer's perspective may depend upon his or her relationship to the patient. We investigated similarities and differences within and between family and paid carers in their reports on the Glasgow Epilepsy Outcome Scale (GEOS), an instrument that quantifies concerns about epilepsy in this population [Epilepsia 42 (2001) 1043]., Methods: GEOS forms were available on 186 patients (108 males; mean age 39 years) across 384 primary respondents (141 staff, 83 family, 160 clinicians) and independently completed secondary respondents (67 staff, 36 family). Data were analysed to consider levels of concern as rated bv staff carers, family members and clinicians, and also to consider inter-rater agreement on the concerns raised., Results: There were significant differences in the magnitude of concern on each sub-scale [concerns about seizures, treatment, caring and social impact; range of F(2,171)=9.5-64.7; all P<0.0001]. Post hoc testing revealed that family members scored all sub-scales more highly than staff carers or clinicians, and that staff carers scored more highly than clinicians on all but one sub-scale. Inter-rater agreement between family members was considerably higher (range of r=0.69-0.91) than between staff carers (r=0.30-0.47) across the GEOS sub-scales. Association between staff and family ratings was also modest (r< or = 0.39)., Conclusions: It is preferable for the same staff member to complete each administration of the GEOS because of inter-staff variability in reporting of concerns. Families provide a consistent, but more extreme, picture and clinicians generally underestimate the concerns of direct caregivers. However, content of concerns varies relatively little across respondents.

Published
2003
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results