Rifampicin/Cotrimoxazole/Isoniazid versus mefloquine or quinine + sulfadoxine- pyrimethamine for malaria: a randomized trial.

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Serval ID
serval:BIB_D203655697C1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Rifampicin/Cotrimoxazole/Isoniazid versus mefloquine or quinine + sulfadoxine- pyrimethamine for malaria: a randomized trial.
Journal
PLoS Clinical Trials
Author(s)
Genton B., Mueller I., Betuela I., Casey G., Ginny M., Alpers M.P., Reeder J.C.
ISSN
1555-5887
Publication state
Published
Issued date
2006
Peer-reviewed
Oui
Volume
1
Number
8
Pages
e38
Language
english
Notes
Publication types: Journal Article
Abstract
OBJECTIVES: Previous studies of a fixed combination including cotrimoxazole, rifampicin, and isoniazid (Cotrifazid) showed efficacy against resistant strains of Plasmodium falciparum in animal models and in small-scale human studies. We conducted a multicentric noninferiority trial to assess the safety and efficacy of Cotrifazid against drug-resistant malaria in Papua New Guinea. DESIGN: The trial design was open-label, block-randomised, comparative, and multicentric. SETTING: The trial was conducted in four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea. PARTICIPANTS: Patients of all ages with recurrent uncomplicated malaria were included. INTERVENTIONS: Patients were randomly assigned to receive Cotrifazid, mefloquine, or the standard treatment of quinine with sulfadoxine-pyrimethamine (SP). OUTCOME MEASURES: Incidence of clinical and laboratory adverse events and rate of clinical and/or parasitological failure at day 14 were recorded. RESULTS: The safety analysis population included 123 patients assigned to Cotrifazid, 123 to mefloquine, and 123 to quinine + SP. The Cotrifazid group experienced lower overall incidence of adverse events than the other groups. Among the efficacy analysis population (72 Cotrifazid, 71 mefloquine, and 75 quinine + SP), clinical failure rate (symptoms and parasite load) on day 14 was equivalent for the three groups (0% for Cotrifazid and mefloquine; 1% for quinine + SP), but parasitological failure rate (P. falciparum asexual blood-stage) was higher for Cotrifazid than for mefloquine or quinine + SP (9% [PCR corrected 8%] versus 0% and 3%, respectively [p = 0.02]). CONCLUSION: Despite what appears to be short-term clinical equivalence, the notable parasitological failure at day 14 in both P. falciparum and P. vivax makes Cotrifazid in its current formulation and regimen a poor alternative combination therapy for malaria.
Pubmed
Web of science
Open Access
Yes
Create date
28/01/2008 11:49
Last modification date
20/08/2019 15:52
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