NCT00959517

Trial of Artesunate Combination Therapy in Pakistan

Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 588 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan. A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.

Detailed description

A randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicated falciparum malaria. Arms: 1. CQ 2. CQ+primaquine 3. CQ+ artesunate 4. SP 5. SP+primaquine 6. SP+artesunate Patients were allocated to treatment groups using a pseudo-randomised table split by age and sex. Primary outcomes: * Clinical and parasitological cure/treatment failure by day 28. Secondary outcomes: * time to resolution of fever * time to clearance of trophozoites * time to clearance of gametocytes * gametocyte carriage on or after day 7 after treatment All clinical assessments and slide readings were carried out by staff blind to treatment arm. Slides were double read.

Conditions

• Uncomplicated Falciparum Malaria

Interventions

Type	Name	Description
DRUG	artesunate (AS)	Recommended dosage over 3 days (for all interventions)
DRUG	sulphadoxine-pyrimethamine (SP)
DRUG	Chloroquine (CQ)
DRUG	primaquine (PQ)

Timeline

• Start date: 2001-07-01
• Primary completion: 2005-06-01
• Completion: 2006-08-01
• First posted: 2009-08-14
• Last updated: 2009-08-14

Locations

1 site across 1 country: Pakistan