NCT00118807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
Last Updated

January 9, 2006

Status Verified

June 1, 2003

First QC Date

July 1, 2005

Last Update Submit

January 6, 2006

Conditions

Malaria

Keywords

malaria treatmentartemisinin based combination therapyPlasmodium falciparumpragmatic trialeffectiveness

Outcome Measures

Primary Outcomes (2)

  • Clinical failure by day 28

  • Incidence of adverse events

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Amodiaquine plus artesunate (AQ/AS)DRUG
Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)DRUG
Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)DRUG

Eligibility Criteria

Age6 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council Laboratories

Banjul, City of Banjul, POBOX273, The Gambia

Location

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

AmodiaquineArtesunatefanasil, pyrimethamine drug combinationChloroquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Sam K Dunyo, PhD

    Medical Research Council

    PRINCIPAL INVESTIGATOR

  • Paul J Milligan, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 12, 2005

Study Start

August 1, 2003

Study Completion

February 1, 2004

Last Updated

January 9, 2006

Record last verified: 2003-06

Locations

TH(1)