Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children

January 6, 2006 updated by: London School of Hygiene and Tropical Medicine

Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children

The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.

Study Type

Interventional

Enrollment

1800

Phase

  • Phase 3

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

  • Gambia
      • Banjul, Gambia, POBOX273
        • Medical Research Council Laboratories

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

6 months to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presentation at health centre with febrile illness
  • Monoinfection with P. falciparum
  • Parasitaemia >=500/microlitre
  • Fever or history of fever

Exclusion Criteria:

  • Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul)
  • Severe malnutrition
  • Clinically evident concomitant disease
  • PCV <20%
  • History of allergy to the study medications
  • Residence outside the study area and hence difficult to follow up

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of adverse events
Clinical failure by day 28

Secondary Outcome Measures

Outcome Measure
Compliance with treatment regimen
Parasitological failure by day 28
Clinical failure by day 14
Parasitological failure rate by day 14
Mean PCV on day 28
Gametocyte carriage rates
Transmissibility after treatment

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

Medical Research Council
National Malaria Control Programme, The Gambia

Investigators

  • Principal Investigator: Sam K Dunyo, PhD, Medical Research Council

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

August 1, 2003

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

July 1, 2005

First Submitted That Met QC Criteria

July 1, 2005

First Posted (ESTIMATE)

July 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2006

Last Update Submitted That Met QC Criteria

January 6, 2006

Last Verified

June 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCC940
  • MRC SCC No. 940

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.

Clinical Trials on Malaria

Clinical Trials on Amodiaquine plus artesunate (AQ/AS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe