Treatment of Uncomplicated Malaria in Benin

This study has been completed.
Sponsor:
Information provided by:
Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT00460369
First received: April 12, 2007
Last updated: April 11, 2008
Last verified: April 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Fanasil, pyrimethamine drug combination
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 August 01, 2014