Cotrifazid Safety and Efficacy Against Malaria
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)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea|
- Clinical treatment failure rate on day 14.
- Incidence of adverse events.
- Parasitological failure rate on day 14
- Fever clearance time
- Parasite clearance time
- Symptoms clearance time
- Occurrence of complications
|Study Start Date:||April 2000|
|Estimated Study Completion Date:||January 2003|
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
|Papua New Guinea|
|Madang and Maprik, Madang and East Sepik Province, Papua New Guinea|
|Principal Investigator:||Blaise Genton, MD, PhD||Swiss Tropical & Public Health Institute|