Trial of Artesunate Combination Therapy in Pakistan

August 13, 2009 updated by: London School of Hygiene and Tropical Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

588

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Peshawar, Pakistan
        • HealthNet International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CQ
Drug: Chloroquine (CQ)
Experimental: CQ+PQ
Drug: Chloroquine (CQ)
Drug: primaquine (PQ)
Experimental: CQ + AS
Drug: Chloroquine (CQ)
Drug: artesunate (AS)
Recommended dosage over 3 days (for all interventions)
Experimental: SP
Drug: sulphadoxine-pyrimethamine (SP)
Experimental: SP + PQ
Drug: primaquine (PQ)
Drug: sulphadoxine-pyrimethamine (SP)
Experimental: SP + AS
Drug: artesunate (AS)
Recommended dosage over 3 days (for all interventions)
Drug: sulphadoxine-pyrimethamine (SP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parasitological outcome after 28 days follow-up
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Asexual parasite clearance by day 7
Time Frame: 7 days
7 days
Gametocyte carriage on or after day 7
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

HealthNet TPO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 14, 2009

Last Update Submitted That Met QC Criteria

August 13, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T26/181/33 A00017
  • TDR A00017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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