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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 3

Locations

Gambia

Study Type

Interventional

Intervention

Amodiaquine plus artesunate (AQ/AS)

Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)

Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)

About this trial

This is an interventional treatment trial for Malaria focused on measuring malaria treatment, artemisinin based combination therapy, Plasmodium falciparum, pragmatic trial, effectiveness

Eligibility Criteria

6 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical Research Council Laboratories

Outcomes

Primary Outcome Measures

Clinical failure by day 28

Incidence of adverse events

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00118807

First Posted

July 1, 2005

Last Updated

January 6, 2006

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Medical Research Council, National Malaria Control Programme, The Gambia

1. Study Identification

Unique Protocol Identification Number

NCT00118807

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2003

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Medical Research Council, National Malaria Control Programme, The Gambia

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

malaria treatment, artemisinin based combination therapy, Plasmodium falciparum, pragmatic trial, effectiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1800 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amodiaquine plus artesunate (AQ/AS)

Intervention Type

Drug

Intervention Name(s)

Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)

Intervention Type

Drug

Intervention Name(s)

Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)

Primary Outcome Measure Information:

Title

Clinical failure by day 28

Title

Incidence of adverse events

Secondary Outcome Measure Information:

Title

Compliance with treatment regimen

Title

Parasitological failure by day 28

Title

Clinical failure by day 14

Title

Parasitological failure rate by day 14

Title

Mean PCV on day 28

Title

Gametocyte carriage rates

Title

Transmissibility after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam K Dunyo, PhD

Organizational Affiliation

Medical Research Council

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul J Milligan, PhD

Organizational Affiliation

London School of Hygiene and Tropical Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Research Council Laboratories

City

Banjul

ZIP/Postal Code

POBOX273

Country

Gambia

12. IPD Sharing Statement

Learn more about this trial

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

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