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

This study has been completed.
Sponsor:
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00137553
First received: August 28, 2005
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Malaria, Falciparum
Drug: Sulfadoxine-pyrimethamine (Fansidar)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Re-appearing parasitaemia

Estimated Enrollment: 60
Study Start Date: May 2001
Estimated Study Completion Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00137553

Locations
Guinea-Bissau
Bandim Health Project
Apartado 861, Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Study Director: Peter Aaby, Professor Bandim Health Project
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00137553     History of Changes
Other Study ID Numbers: PSB-2001-Fansidar
Study First Received: August 28, 2005
Last Updated: March 15, 2010
Health Authority: Guinea-Bissau: Ministry of Health
Denmark: Ethics Committee

Keywords provided by Bandim Health Project:
Children
malaria
sulfadoxine-pyrimethamine
Guinea-Bissau
treatment

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014