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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.

Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine + Sulfadoxine- Pyrimethamine for Malaria: A Randomized Trial