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1. 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

2. 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

3. Effect of systematic tuberculosis detection on mortality in young children with severe pneumonia in countries with high incidence of tuberculosis: a stepped-wedge cluster-randomised trial

Author

Marcy, O, Wobudeya, E, Font, H, Vessière, A, Chabala, C, Khosa, C, Taguebue, J-V, Moh, R, Mwanga-Amumpaire, J, Lounnas, M, Mulenga, V, Mavale, S, Chilundo, J, Rego, D, Nduna, B, Shankalala, P, Chirwa, U, De Lauzanne, A, Dim, B, Tiogouo Ngouana, E, Folquet Amorrissani, M, Cisse, L, Amon Tanoh Dick, F, Komena, EA, Kwedi Nolna, S, Businge, G, Natukunda, N, Cumbe, S, Mbekeka, P, Kim, A, Kheang, C, Pol, S, Maleche-Obimbo, E, Seddon, JA, Mao, TE, Graham, SM, Delacourt, C, Borand, L, Bonnet, M, Serre, A, Badrichani, A, Razafimanantsoa, M, Poublan, J, Roucher, C, Occelli, E, Beuscart, A, Charpin, A, Habiyambere, G, Mesnier, S, Balestre, E, Bhatta, B, Maillard, A-L, Orne-Gliemann, J, Baillet, E, Koskas, N, D'Elbée, M, Gabillard, D, Huyen, M, Espérou, H, Couffin-Cadiergues, S, Kuppers, A, Hamze, B, BORAND, L, de LAUZANNE, A, DIM, B, Keang, C, PRING, L, YIN, S, SARITH, C, PHAN, C, NHEUONG, S, LY, S, KAING, S, SRENG, V, LUN, E, SAY, L, SUOM, S, FERHY, R, SO, D, BORN, S, PAL, S, NANG, B, MAO, TE, KIM, A, Srey, V, Kan, P, Hout, L, Ith, S, Oum, S, Sau, S, Ho, KH, Kith, D, Nuch, N, Horm, CL, Sophon, C, Roeungdeth, B, MENG, C, RITH, R, PHY, S, SOR, C, SAO, V, KHAT, S, MAK, B, UY, A, KHAY, S, SOM, K, HACH, R, SOK, H, KUON, S, HENG, S, SENG, A, NIM, S, PAN, R, KIM, S, SREY LEAP, K, NET, B, NOUN, V, LAY, D, MANY, C, Seng, S, Ly, V, So, S, Oun, S, CHEY, S, CHHEA, R, BAONG, L, THOUNG, V, KHEANG, C, BY, B, Nguon, V, MEACH, E, Tek, S, Ngeav, S, Lun, T, HEM, D, CHUT, N, SARIK, S, NANG, H, MEACH, M, SRENG, S, SAR, D, KIN, R, ROS, P, DORN, C, KAK, C, Sambath, SL, Son, L, Bin, L, Pengong, E, Khutsorn, S, Seang, S, Soun, V, Vong, V, Khoeung, C, Um, P, Bou, S, Song Pich, S, Nim, P, Khat, S, Ban Si, N, Ream, S, Ing, S, Chann, P, Ngeth, S, Sun, M, Chhoeung, S, Sean, S, Prak, R, Amboua Schouame Onambele, A, Hycenth, N, Melingui, B, Nkembe Medounmga, A, Hougnang Tatmi, L, Etemgoua, N, Kouesso, V, Bugin, J, Nzedjom, C, Ngoya, R, Eyike, J, Loudjom, E, Lonsti, R, Dang, L, Bintar, E, Njayong, C, Ngonsoa O, C, Ndzeukap, I, Dzoyem, P, Dzokou, C, Dindo, B, Aka Bony, R, Kouadio, C, Danho, S, Goli, M, Folquet, M, Itchy, MV, Sidibé, A, Cissé, L, Ouattara, J, Konaté, M, Amon-Tanoh Dick, F, Cardena, M, Adonis-Koffi, L, Eugenie, D, Kouamé, F, Menan, H, Inwoley, A, Ouassa, T, Nguessan, MS, Manhiça, E, Zitha, A, Chiúle, V, Muxanga, E, Gune, I, Lima, Y, Ribeiro, J, Maxanguana, F, Morais, N, Manhiça, J, Give, J, Atumane, J, Lucas, G, Thai, A, Chave, A, Guambe, L, Issa, F, Carneiro, R, Pene, N, Florindo, N, Machel, D, Cumbane, C, Mendes, H, Kitungwa, M, Muianga, V, Tamele, H, Sulude, A, Mabota, R, Comandante, H, Massangaie, A, Businge, GB, Namulinda, F, Sserunjogi, R, Nassozi, R, Barungi, C, Aanyu, H, Muwonge, D, Kagoya, E, Aciparu, S, Chemutai, S, Ntambi, S, Wasswa, A, Nangozi, J, Tagoola, A, Kenneth, S, Lubega, JP, Nassali, A, Tagobera, J, Agwang, C, Kalembe, F, Ajambo, A, Aguti, E, Kasibante, S, Matende, H, Odongo, IO, Mwanga Amumpaire, J, Ngabirano, G, Kakwenza, P, Nuwamanya, S, Nyangoma, M, Nabbuto, J, Abok, F, Arinaitwe, R, Birungi, D, Mwesigwa, E, Atwine, D, Mbega, H, Orikiriza, P, Taremwa, I, Turyashemererwa, E, Derrick, H, Nyehangane, D, Kaitano, R, Logoose, S, Businge, S, Ntambi, C, Mugabi, J, Mzee, J, Besigye, J, Kanzira, S, Turyatemba, P, Twebaze, F, Hambulo, C, Kapotwe, V, Ngambi, M, Kasakwa, K, Kapula, C, Zulu, S, Nawakwi, G, Siasulingana, T, Chilonga, J, Chimbini, M, Chilanga, M, Inambao, M, Mwambazi, M, Halende, B, Mumba, W, Mankunshe, E, Silavwe, M, Chakopo, M, Moono, R, Marcy, O, Wobudeya, E, Font, H, Vessière, A, Chabala, C, Khosa, C, Taguebue, J-V, Moh, R, Mwanga-Amumpaire, J, Lounnas, M, Mulenga, V, Mavale, S, Chilundo, J, Rego, D, Nduna, B, Shankalala, P, Chirwa, U, De Lauzanne, A, Dim, B, Tiogouo Ngouana, E, Folquet Amorrissani, M, Cisse, L, Amon Tanoh Dick, F, Komena, EA, Kwedi Nolna, S, Businge, G, Natukunda, N, Cumbe, S, Mbekeka, P, Kim, A, Kheang, C, Pol, S, Maleche-Obimbo, E, Seddon, JA, Mao, TE, Graham, SM, Delacourt, C, Borand, L, Bonnet, M, Serre, A, Badrichani, A, Razafimanantsoa, M, Poublan, J, Roucher, C, Occelli, E, Beuscart, A, Charpin, A, Habiyambere, G, Mesnier, S, Balestre, E, Bhatta, B, Maillard, A-L, Orne-Gliemann, J, Baillet, E, Koskas, N, D'Elbée, M, Gabillard, D, Huyen, M, Espérou, H, Couffin-Cadiergues, S, Kuppers, A, Hamze, B, BORAND, L, de LAUZANNE, A, DIM, B, Keang, C, PRING, L, YIN, S, SARITH, C, PHAN, C, NHEUONG, S, LY, S, KAING, S, SRENG, V, LUN, E, SAY, L, SUOM, S, FERHY, R, SO, D, BORN, S, PAL, S, NANG, B, MAO, TE, KIM, A, Srey, V, Kan, P, Hout, L, Ith, S, Oum, S, Sau, S, Ho, KH, Kith, D, Nuch, N, Horm, CL, Sophon, C, Roeungdeth, B, MENG, C, RITH, R, PHY, S, SOR, C, SAO, V, KHAT, S, MAK, B, UY, A, KHAY, S, SOM, K, HACH, R, SOK, H, KUON, S, HENG, S, SENG, A, NIM, S, PAN, R, KIM, S, SREY LEAP, K, NET, B, NOUN, V, LAY, D, MANY, C, Seng, S, Ly, V, So, S, Oun, S, CHEY, S, CHHEA, R, BAONG, L, THOUNG, V, KHEANG, C, BY, B, Nguon, V, MEACH, E, Tek, S, Ngeav, S, Lun, T, HEM, D, CHUT, N, SARIK, S, NANG, H, MEACH, M, SRENG, S, SAR, D, KIN, R, ROS, P, DORN, C, KAK, C, Sambath, SL, Son, L, Bin, L, Pengong, E, Khutsorn, S, Seang, S, Soun, V, Vong, V, Khoeung, C, Um, P, Bou, S, Song Pich, S, Nim, P, Khat, S, Ban Si, N, Ream, S, Ing, S, Chann, P, Ngeth, S, Sun, M, Chhoeung, S, Sean, S, Prak, R, Amboua Schouame Onambele, A, Hycenth, N, Melingui, B, Nkembe Medounmga, A, Hougnang Tatmi, L, Etemgoua, N, Kouesso, V, Bugin, J, Nzedjom, C, Ngoya, R, Eyike, J, Loudjom, E, Lonsti, R, Dang, L, Bintar, E, Njayong, C, Ngonsoa O, C, Ndzeukap, I, Dzoyem, P, Dzokou, C, Dindo, B, Aka Bony, R, Kouadio, C, Danho, S, Goli, M, Folquet, M, Itchy, MV, Sidibé, A, Cissé, L, Ouattara, J, Konaté, M, Amon-Tanoh Dick, F, Cardena, M, Adonis-Koffi, L, Eugenie, D, Kouamé, F, Menan, H, Inwoley, A, Ouassa, T, Nguessan, MS, Manhiça, E, Zitha, A, Chiúle, V, Muxanga, E, Gune, I, Lima, Y, Ribeiro, J, Maxanguana, F, Morais, N, Manhiça, J, Give, J, Atumane, J, Lucas, G, Thai, A, Chave, A, Guambe, L, Issa, F, Carneiro, R, Pene, N, Florindo, N, Machel, D, Cumbane, C, Mendes, H, Kitungwa, M, Muianga, V, Tamele, H, Sulude, A, Mabota, R, Comandante, H, Massangaie, A, Businge, GB, Namulinda, F, Sserunjogi, R, Nassozi, R, Barungi, C, Aanyu, H, Muwonge, D, Kagoya, E, Aciparu, S, Chemutai, S, Ntambi, S, Wasswa, A, Nangozi, J, Tagoola, A, Kenneth, S, Lubega, JP, Nassali, A, Tagobera, J, Agwang, C, Kalembe, F, Ajambo, A, Aguti, E, Kasibante, S, Matende, H, Odongo, IO, Mwanga Amumpaire, J, Ngabirano, G, Kakwenza, P, Nuwamanya, S, Nyangoma, M, Nabbuto, J, Abok, F, Arinaitwe, R, Birungi, D, Mwesigwa, E, Atwine, D, Mbega, H, Orikiriza, P, Taremwa, I, Turyashemererwa, E, Derrick, H, Nyehangane, D, Kaitano, R, Logoose, S, Businge, S, Ntambi, C, Mugabi, J, Mzee, J, Besigye, J, Kanzira, S, Turyatemba, P, Twebaze, F, Hambulo, C, Kapotwe, V, Ngambi, M, Kasakwa, K, Kapula, C, Zulu, S, Nawakwi, G, Siasulingana, T, Chilonga, J, Chimbini, M, Chilanga, M, Inambao, M, Mwambazi, M, Halende, B, Mumba, W, Mankunshe, E, Silavwe, M, Chakopo, M, and Moono, R

Abstract

Background: Tuberculosis diagnosis might be delayed or missed in children with severe pneumonia because this diagnosis is usually only considered in cases of prolonged symptoms or antibiotic failure. Systematic tuberculosis detection at hospital admission could increase case detection and reduce mortality. Methods: We did a stepped-wedge cluster-randomised trial in 16 hospitals from six countries (Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Uganda, and Zambia) with high incidence of tuberculosis. Children younger than 5 years with WHO-defined severe pneumonia received either the standard of care (control group) or standard of care plus Xpert MTB/RIF Ultra (Xpert Ultra; Cepheid, Sunnyvale, CA, USA) on nasopharyngeal aspirate and stool samples (intervention group). Clusters (hospitals) were progressively switched from control to intervention at 5-week intervals, using a computer-generated random sequence, stratified on incidence rate of tuberculosis at country level, and masked to teams until 5 weeks before switch. We assessed the effect of the intervention on primary (12-week all-cause mortality) and secondary (including tuberculosis diagnosis) outcomes, using generalised linear mixed models. The primary analysis was by intention to treat. We described outcomes in children with severe acute malnutrition in a post hoc analysis. This study is registered with ClinicalTrials.gov (NCT03831906) and the Pan African Clinical Trial Registry (PACTR202101615120643). Findings: From March 21, 2019, to March 30, 2021, we enrolled 1401 children in the control group and 1169 children in the intervention group. In the intervention group, 1140 (97·5%) children had nasopharyngeal aspirates and 942 (80·6%) had their stool collected; 24 (2·1%) had positive Xpert Ultra. At 12 weeks, 110 (7·9%) children in the control group and 91 (7·8%) children in the intervention group had died (adjusted odds ratio [OR] 0·986, 95% CI 0·597–1·630, p=0·957), and 74 (5·3%) children in the control group

Published
2022

4. 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

5. 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

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