Trial of Artesunate Combination Therapy in Pakistan

Phase 2

Completed

• Conditions: Uncomplicated Falciparum Malaria
• Interventions: Drug: Chloroquine (CQ); Drug: sulphadoxine-pyrimethamine (SP); Drug: artesunate (AS); Drug: primaquine (PQ)

• Registration Number: NCT00959517
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief 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.

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2005-06
• Study Completion: 2006-08
• Status Verified: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Last Update Submitted: 2009-08-13
• Study First Posted: 2009-08-14
• Last Update Posted: 2009-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 588

Inclusion Criteria

• presentation at basic health unit with suspected clinical malaria
• mono-infection infection with P. falciparum confirmed by microscopy
• over 2 years of age (no upper age restriction)
• weight over 5 kg (no upper weight restriction)
• if of child bearing age then non-pregnant and willing to remain so for the duration of the study
• greater than 1 asexual parasite per 10 fields
• understands and is willing to sign the consent form
• a resident in the study site willing to collaborate for a full period of follow-up
• no signs of severe malaria

Exclusion Criteria

• other serious disease (e.g., cardiac, renal or hepatic)
• in women of child bearing age, pregnancy
• allergy to any of the study drugs or related compounds
• reports to have used any malaria drugs in the last 21 days
• other species of malaria seen
• signs of severe malaria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CQ	Chloroquine (CQ)	-
SP + PQ	primaquine (PQ)	-
SP	sulphadoxine-pyrimethamine (SP)	-
CQ+PQ	primaquine (PQ)	-
CQ+PQ	Chloroquine (CQ)	-
CQ + AS	artesunate (AS)	-
CQ + AS	Chloroquine (CQ)	-
SP + PQ	sulphadoxine-pyrimethamine (SP)	-
SP + AS	artesunate (AS)	-
SP + AS	sulphadoxine-pyrimethamine (SP)	-

Primary Outcome Measures

Name	Time	Method
Parasitological outcome after 28 days follow-up	28 days

Secondary Outcome Measures

Name	Time	Method
Asexual parasite clearance by day 7	7 days
Gametocyte carriage on or after day 7	7 days

Trial Locations

Locations (1)

HealthNet International; 🇵🇰 Peshawar, Pakistan