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Treatment of Uncomplicated Malaria in Benin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460369
First Posted: April 13, 2007
Last Update Posted: April 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut de Recherche pour le Developpement
  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
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

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 ]

Secondary Outcome Measures:
  • effectiveness comparisons (PCR corrected) [ Time Frame: day 14 and day 42 ]
  • incidence of adverse events [ Time Frame: day 42 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 119 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 12, 2007
First Posted: April 13, 2007
Last Update Posted: April 14, 2008
Last Verified: April 2008

Keywords provided by Institut de Recherche pour le Developpement:
uncomplicated malaria
children
treatment
effectiveness

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Lumefantrine
Artemether
Artemisinins
Pyrimethamine
Sulfadoxine
Artemether-lumefantrine combination
Amodiaquine
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents