NCT00460369

Brief Summary

Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised. The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome. Expected total enrollment: 225 patients Study start: April 2007; expected completion: December 2007

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

April 12, 2007

Last Update Submit

April 11, 2008

Conditions

Uncomplicated Malaria

Keywords

uncomplicated malariachildrentreatmenteffectiveness

Outcome Measures

Primary Outcomes (1)

  • efficacy

    day 28

Secondary Outcomes (2)

  • effectiveness comparisons (PCR corrected)

    day 14 and day 42

  • incidence of adverse events

    day 42

Study Arms (3)

1

ACTIVE COMPARATOR

sulfadoxine-pyrimethamine

Drug: sulfadoxine-pyrimethamine

2

ACTIVE COMPARATOR

artemether-lumefantrine

Drug: artemether-lumefantrine

3

ACTIVE COMPARATOR

amodiaquine-artesunate coformulation

Drug: amodiaquine-artesunate coformulation

Interventions

sulfadoxine-pyrimethamineDRUG

tablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake

Also known as: Fansidar
1
artemether-lumefantrineDRUG

tablets 20/120 mg * 1 tablet twice daily for 3 days below 15 kg of bodyweight * 2 tablets twice daily for 3 days below 24 kg of bodyweight * 3 tablets twice daily for 3 days below 35 kg of bodyweight

Also known as: coartem
2
amodiaquine-artesunate coformulationDRUG

one 25mg/67,5mg tablet, once daily for 3 days below 9 kg one 50/135mg tablet, once daily for 3 days below 18 kg

Also known as: coarsucam
3

Eligibility Criteria

Age6 Months - 119 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months old
  • fever or history of fever of less than 24 hours
  • p falciparum parasitemia \> 1000 trophozoïtes/µL
  • informed consent signed

You may not qualify if:

  • \< 5 kg
  • danger or severity signs of malaria
  • known underlying chronic disease
  • Hb \< 5g/dL
  • adequate malaria treatment taken within 3 days before visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de santé

Allada, Benin

Location

Related Publications (1)

  • Faucher JF, Aubouy A, Adeothy A, Cottrell G, Doritchamou J, Gourmel B, Houze P, Kossou H, Amedome H, Massougbodji A, Cot M, Deloron P. Comparison of sulfadoxine-pyrimethamine, unsupervised artemether-lumefantrine, and unsupervised artesunate-amodiaquine fixed-dose formulation for uncomplicated plasmodium falciparum malaria in Benin: a randomized effectiveness noninferiority trial. J Infect Dis. 2009 Jul 1;200(1):57-65. doi: 10.1086/599378.

    PMID: 19469703DERIVED

MeSH Terms

Interventions

fanasil, pyrimethamine drug combinationArtemether, Lumefantrine Drug Combination

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jean-François Faucher, MD PhD

    Institut de recherche pour le développement UR010

    PRINCIPAL INVESTIGATOR

  • Philippe Deloron, MD PhD

    Institut de Recherche pour le Développement UR010

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 12, 2007

First Posted

April 13, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

BE(1)