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The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children

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. Identifier: NCT00137553
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : March 16, 2010
Information provided by:
Bandim Health Project

Brief Summary:

Children participating in a study evaluating the efficacy of chloroquine and amodiaquine for the treatment of malaria will, if getting malaria during follow-up, be re-treated with sulfadoxine-pyrimethamine (SP) in accordance with the recommendations of the National Malaria Programme.

To compare the actual efficacy of SP with that in 1995 - 1996 we, the investigators of the Bandim Health Project, will visit these children once a week for 5 weeks. A finger prick blood sample will be collected for a malaria test.

Children with malaria during follow-up will be treated according to the guidelines of the Bandim Health Centre.

Condition or disease Intervention/treatment Phase
Malaria, Falciparum Drug: Sulfadoxine-pyrimethamine (Fansidar) Phase 4

Detailed Description:

The Bandim Health Project studies the efficacy of different treatment regimens for malaria in children. If the included children during follow-up get malaria again they are, according to the recommendations of the National Malaria Programme, treated with sulfadoxine-pyrimethamine (SP).

In 1995 - 1996 the efficacy of this re-treatment regimen was evaluated in the same area.

To evaluate if treatment with SP is still efficient we want to follow children included in a study comparing treatment with chloroquine and amodiaquine having recrudescent malaria for 35 days following the re-treatment with SP.

Children with reappearing parasitaemia will be treated with SP. If accepting to participate in this study the children will be visited once a week and a capillary blood sample will be drawn. The blood sample taken on the day of reappearing parasitaemia in the chloroquine/amodiaquine study will be used as the day 0 blood sample in the SP-study.

If the child gets malaria during the follow-up he will be treated according to the guidelines of the Bandim Health Centre. All treatment during follow-up will be free.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau
Study Start Date : May 2001
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Re-appearing parasitaemia

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.

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Malaria symptoms plus positive malaria film
  • > 20 parasites per 200 leukocytes
  • Treatment failure in a study comparing chloroquine and amodiaquine
  • Informed consent

Exclusion Criteria:

  • Stated allergy to sulfadoxine and/or pyrimethamine

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 identifier (NCT number): NCT00137553

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Bandim Health Project
Apartado 861, Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
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Study Director: Peter Aaby, Professor Bandim Health Project
Layout table for additonal information Identifier: NCT00137553    
Other Study ID Numbers: PSB-2001-Fansidar
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by Bandim Health Project:
Additional relevant MeSH terms:
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Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents