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Treatment of Uncomplicated Malaria in Benin

Primary Purpose

Uncomplicated Malaria

Status
Completed
Phase
Not Applicable
Locations
Benin
Study Type
Interventional
Intervention
sulfadoxine-pyrimethamine
artemether-lumefantrine
amodiaquine-artesunate coformulation
Sponsored by
Institut de Recherche pour le Developpement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated Malaria focused on measuring uncomplicated malaria, children, treatment, effectiveness

Eligibility Criteria

6 Months - 119 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 6-119 months old
  • fever or history of fever of less than 24 hours
  • p falciparum parasitemia > 1000 trophozoïtes/µL
  • informed consent signed

Exclusion Criteria:

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

Sites / Locations

  • Centre de santé

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

sulfadoxine-pyrimethamine

artemether-lumefantrine

amodiaquine-artesunate coformulation

Outcomes

Primary Outcome Measures

efficacy

Secondary Outcome Measures

effectiveness comparisons (PCR corrected)
incidence of adverse events

Full Information

First Posted
April 12, 2007
Last Updated
April 11, 2008
Sponsor
Institut de Recherche pour le Developpement
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1. Study Identification

Unique Protocol Identification Number
NCT00460369
Brief Title
Treatment of Uncomplicated Malaria in Benin
Official Title
Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut de Recherche pour le Developpement

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Malaria
Keywords
uncomplicated malaria, children, treatment, effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
sulfadoxine-pyrimethamine
Arm Title
2
Arm Type
Active Comparator
Arm Description
artemether-lumefantrine
Arm Title
3
Arm Type
Active Comparator
Arm Description
amodiaquine-artesunate coformulation
Intervention Type
Drug
Intervention Name(s)
sulfadoxine-pyrimethamine
Other Intervention Name(s)
Fansidar
Intervention Description
tablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake
Intervention Type
Drug
Intervention Name(s)
artemether-lumefantrine
Other Intervention Name(s)
coartem
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
amodiaquine-artesunate coformulation
Other Intervention Name(s)
coarsucam
Intervention Description
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
Primary Outcome Measure Information:
Title
efficacy
Time Frame
day 28
Secondary Outcome Measure Information:
Title
effectiveness comparisons (PCR corrected)
Time Frame
day 14 and day 42
Title
incidence of adverse events
Time Frame
day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
119 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6-119 months old fever or history of fever of less than 24 hours p falciparum parasitemia > 1000 trophozoïtes/µL informed consent signed Exclusion Criteria: < 5 kg danger or severity signs of malaria known underlying chronic disease Hb < 5g/dL adequate malaria treatment taken within 3 days before visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François Faucher, MD PhD
Organizational Affiliation
Institut de recherche pour le développement UR010
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Deloron, MD PhD
Organizational Affiliation
Institut de Recherche pour le Développement UR010
Official's Role
Study Director
Facility Information:
Facility Name
Centre de santé
City
Allada
Country
Benin

12. IPD Sharing Statement

Citations:
PubMed Identifier
19469703
Citation
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.
Results Reference
derived

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Treatment of Uncomplicated Malaria in Benin

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