Trial of Artesunate Combination Therapy in Pakistan

Uncomplicated Falciparum Malaria Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Uncomplicated Falciparum Malaria

• NCT number: NCT00959517
• Study type: Interventional
• Source: London School of Hygiene and Tropical Medicine
• Status: Completed
• Phase: Phase 2
• Start date: July 2001
• Completion date: August 2006