Treatment of Uncomplicated Malaria in Benin

Sponsor

Institut de Recherche pour le Developpement (Other)

Overall Status

Completed

CT.gov ID

NCT00460369

Collaborator

(none)

240

Enrollment

Location

Arms

Duration (Months)

34.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Malaria	Drug: sulfadoxine-pyrimethamine Drug: artemether-lumefantrine Drug: amodiaquine-artesunate coformulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 sulfadoxine-pyrimethamine	Drug: sulfadoxine-pyrimethamine tablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake Other Names: Fansidar
Active Comparator: 2 artemether-lumefantrine	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 Other Names: coartem
Active Comparator: 3 amodiaquine-artesunate coformulation	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 Other Names: coarsucam

Arm

Intervention/Treatment

Active Comparator: 1

sulfadoxine-pyrimethamine

Drug: sulfadoxine-pyrimethamine

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

Other Names:

Fansidar

Active Comparator: 2

artemether-lumefantrine

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

Other Names:

coartem

Active Comparator: 3

amodiaquine-artesunate coformulation

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

Other Names:

coarsucam

Outcome Measures

Primary Outcome Measures

efficacy [day 28]

Secondary Outcome Measures

effectiveness comparisons (PCR corrected) [day 14 and day 42]
incidence of adverse events [day 42]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 119 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de santé	Allada		Benin

Sponsors and Collaborators

Institut de Recherche pour le Developpement

Investigators

Principal Investigator: Jean-François Faucher, MD PhD, Institut de recherche pour le développement UR010
Study Director: Philippe Deloron, MD PhD, Institut de Recherche pour le Développement UR010