OBJECTIVE: To assess the efficacy of methylene blue (MB) monotherapy in semi-immune adults with uncomplicated malaria in Burkina Faso. METHODS: In an open-label controlled phase II study with 60 semi-immune adults with uncomplicated falciparum malaria in Nouna, north-western Burkina Faso, MB monotherapy (390 mg twice daily) was given sequentially to groups of 20 adults for 7 days (MB7), 5 days (MB5) and 3 days (MB3), respectively. The primary outcome was the rate of adequate clinical and parasitological response (ACPR) on day 28 of follow-up. RESULTS: Of the study population, 27/58 (47%) and 5/51 (10%) patients still had parasites on days 2 and 3, respectively, of follow-up resulting in 9/58 (16%) early treatment failures. By day 14, no recrudescence was observed but in 4/19 (MB5) and 2/20 (MB3) individuals by day 28. The PCR-corrected rate of ACPR was 72%, 58% and 85% in groups 7, 5 and 3, respectively, by per protocol analysis. Self-limiting dysuria was the most frequent adverse event. CONCLUSIONS: MB acts slowly against the blood stages of P. falciparum. MB alone needs to be given for at least 7 days to be efficacious in the treatment of falciparum malaria but should be used in combination with a fast acting antimalarial.
RCT Entities:
OBJECTIVE: To assess the efficacy of methylene blue (MB) monotherapy in semi-immune adults with uncomplicated malaria in Burkina Faso. METHODS: In an open-label controlled phase II study with 60 semi-immune adults with uncomplicated falciparum malaria in Nouna, north-western Burkina Faso, MB monotherapy (390 mg twice daily) was given sequentially to groups of 20 adults for 7 days (MB7), 5 days (MB5) and 3 days (MB3), respectively. The primary outcome was the rate of adequate clinical and parasitological response (ACPR) on day 28 of follow-up. RESULTS: Of the study population, 27/58 (47%) and 5/51 (10%) patients still had parasites on days 2 and 3, respectively, of follow-up resulting in 9/58 (16%) early treatment failures. By day 14, no recrudescence was observed but in 4/19 (MB5) and 2/20 (MB3) individuals by day 28. The PCR-corrected rate of ACPR was 72%, 58% and 85% in groups 7, 5 and 3, respectively, by per protocol analysis. Self-limiting dysuria was the most frequent adverse event. CONCLUSIONS:MB acts slowly against the blood stages of P. falciparum. MB alone needs to be given for at least 7 days to be efficacious in the treatment of falciparum malaria but should be used in combination with a fast acting antimalarial.
Authors: Sophie H Adjalley; Geoffrey L Johnston; Tao Li; Richard T Eastman; Eric H Ekland; Abraham G Eappen; Adam Richman; B Kim Lee Sim; Marcus C S Lee; Stephen L Hoffman; David A Fidock Journal: Proc Natl Acad Sci U S A Date: 2011-10-31 Impact factor: 11.205
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Authors: Seydou O Doumbia; Daouda Ndiaye; Ousmane A Koita; Mahamadou Diakité; Davis Nwakanma; Mamadou Coulibaly; Sekou F Traoré; Joseph Keating; Danny A Milner; Jean-Louis Ndiaye; Papa Diogoye Sene; Ambroise Ahouidi; Tandakha N Dieye; Oumar Gaye; Joseph Okebe; Serign J Ceesay; Alfred Ngwa; Eniyou C Oriero; Lassana Konaté; Ngayo Sy; Musa Jawara; Ousmane Faye; Moussa Kéita; Moussa Cissé; Nafomon Sogoba; Belco Poudiougou; Sory Diawara; Lansana Sangaré; Tinzana Coulibaly; Ibrahima Seck; Ismaela Abubakar; Jules Gomis; Frances J Mather; Aliou Sissako; Ayouba Diarra; Balla Kandeh; Christopher Whalen; Brian Moyer; Obinna Nnedu; Oumar Thiero; Amy K Bei; Rachel Daniels; Kazutoyo Miura; Carole A Long; Rick M Fairhurst; Manoj Duraisingh; Marc A T Muskavitch; Umberto D'Alessandro; David J Conway; Sarah K Volkman; Clarissa Valim; Dyann F Wirth; Donald J Krogstad Journal: Acta Trop Date: 2011-11-28 Impact factor: 3.112