NCT00322907

Cotrifazid Safety and Efficacy Against Malaria

A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (planned)
• Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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

Conditions

• Clinical Malaria

Interventions

Type	Name	Description
DRUG	Cotrifazid vs mefloquine or quinine+SP

Timeline

• Start date: 2000-04-01
• Completion: 2003-01-01
• First posted: 2006-05-08
• Last updated: 2006-05-08

Locations

1 site across 1 country: Papua New Guinea