Cotrifazid Safety and Efficacy Against Malaria
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322907
|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|