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Treatment of Uncomplicated Malaria in Benin

NCT ID: NCT00460369

Last Updated: 2008-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Uncomplicated Malaria

Keywords

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uncomplicated malaria children treatment effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

sulfadoxine-pyrimethamine

Group Type ACTIVE_COMPARATOR

sulfadoxine-pyrimethamine

Intervention Type DRUG

tablets 1,25/25 mg

1 tablet per 20 kg of body weight Single drug intake

2

artemether-lumefantrine

Group Type ACTIVE_COMPARATOR

artemether-lumefantrine

Intervention Type DRUG

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

3

amodiaquine-artesunate coformulation

Group Type ACTIVE_COMPARATOR

amodiaquine-artesunate coformulation

Intervention Type DRUG

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

Interventions

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sulfadoxine-pyrimethamine

tablets 1,25/25 mg

1 tablet per 20 kg of body weight Single drug intake

Intervention Type DRUG

artemether-lumefantrine

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

amodiaquine-artesunate coformulation

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

Intervention Type DRUG

Other Intervention Names

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Fansidar coartem coarsucam

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

119 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role lead

Responsible Party

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Institut de Recherche pour le Développement

Principal Investigators

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Jean-François Faucher, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de recherche pour le développement UR010

Philippe Deloron, MD PhD

Role: STUDY_DIRECTOR

Institut de Recherche pour le Développement UR010

Locations

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Centre de santé

Allada, , Benin

Site Status

Countries

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Benin

References

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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.

Reference Type DERIVED
PMID: 19469703 (View on PubMed)

Other Identifiers

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Malariallada

Identifier Type: -

Identifier Source: org_study_id