Clinical Malaria Clinical Trial
Official title:
A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea
The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)
Design: Open-label, block-randomised, comparative, multicentric trial. Setting: 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 Intervention: Random
assignment to receive either Cotrifazid, mefloquine or the standard treatment of
quinine+sulfadoxine/pyrimethamine (SP).
Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical
and/or parasitological failure at day 14
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment