Treatment of Uncomplicated Malaria in Benin - Full Text View

Purpose

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	Intervention
Uncomplicated Malaria	Drug: sulfadoxine-pyrimethamine Drug: artemether-lumefantrine Drug: amodiaquine-artesunate coformulation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Artemether Lumefantrine

U.S. FDA Resources

Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:

efficacy [ Time Frame: day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

effectiveness comparisons (PCR corrected) [ Time Frame: day 14 and day 42 ] [ Designated as safety issue: No ]
incidence of adverse events [ Time Frame: day 42 ] [ Designated as safety issue: Yes ]

Enrollment:	240
Study Start Date:	April 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: coarsucam

Eligibility

Ages Eligible for Study:	6 Months to 119 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460369

Locations

Benin
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

More Information

No publications provided by Institut de Recherche pour le Developpement

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Faucher JF, Aubouy A, Adeothy A, Cottrell G, Doritchamou J, Gourmel B, Houzé 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.

Responsible Party:	Faucher, Institut de Recherche pour le Développement
ClinicalTrials.gov Identifier:	NCT00460369 History of Changes
Other Study ID Numbers:	Malariallada
Study First Received:	April 12, 2007
Last Updated:	April 11, 2008
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Institut de Recherche pour le Developpement:

uncomplicated malaria
children
treatment
effectiveness

Additional relevant MeSH terms:

Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Artemether
Artemisinins
Artesunate
Sulfadoxine-pyrimethamine
Lumefantrine
Artemether-lumefantrine combination
Amodiaquine, artesunate drug combination
Antimalarials

Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on May 16, 2013