NCT00118794

Brief Summary

Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1 month 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

February 1, 2006

Status Verified

January 1, 2005

First QC Date

July 1, 2005

Last Update Submit

January 31, 2006

Conditions

Malaria

Keywords

uncomplicated malariaG6PD deficiencyhaemolytic anaemiaLapdapArtemsinin based combination treatmentcompliancepragmatic trials

Outcome Measures

Primary Outcomes (1)

  • Clinical failure by day 28

Secondary Outcomes (6)

  • Incidence of severe anaemia by day 28

  • Compliance

  • Incidence of adverse events

  • Parasitological failure by day 28

  • Clinical and parasitological failure rates by day 14

  • +1 more secondary outcomes

Interventions

Chlorproguanil-dapsone (Lapdap)DRUG
Lumefantrine-artemether (Coartemether )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

Related Publications (1)

  • Dunyo S, Sirugo G, Sesay S, Bisseye C, Njie F, Adiamoh M, Nwakanma D, Diatta M, Janha R, Sisay Joof F, Temple B, Snell P, Conway D, Walton R, Cheung YB, Milligan P. Randomized trial of safety and effectiveness of chlorproguanil-dapsone and lumefantrine-artemether for uncomplicated malaria in children in the Gambia. PLoS One. 2011;6(6):e17371. doi: 10.1371/journal.pone.0017371. Epub 2011 Jun 7.

    PMID: 21666744DERIVED

MeSH Terms

Conditions

MalariaGlucosephosphate Dehydrogenase DeficiencyAnemia, HemolyticPatient Compliance

Interventions

chloroguanil, dapsone drug combinationArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesAnemia, Hemolytic, CongenitalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Paul J Milligan, BSc MSc PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Sam K Dunyo, MD PhD

    Medical Research Council

    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

September 1, 2004

Study Completion

June 1, 2005

Last Updated

February 1, 2006

Record last verified: 2005-01

Locations

TH(1)