MedDataX Logo

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

NCT ID: NCT00118807

Last Updated: 2006-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amodiaquine plus artesunate (AQ/AS)

Intervention Type DRUG

Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)

Intervention Type DRUG

Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

National Malaria Control Programme, The Gambia

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sam K Dunyo, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council

Paul J Milligan, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Research Council Laboratories

Banjul, City of Banjul, The Gambia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

The Gambia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MRC SCC No. 940

Identifier Type: -

Identifier Source: secondary_id

SCC940

Identifier Type: -

Identifier Source: org_study_id