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
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
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
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

ClinicalTrials.gov processed this record on April 17, 2014