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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137553
First Posted: August 30, 2005
Last Update Posted: March 16, 2010
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:
Bandim Health Project
August 28, 2005
August 30, 2005
March 16, 2010
May 2001
Not Provided
Re-appearing parasitaemia
Same as current
Complete list of historical versions of study NCT00137553 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malaria, Falciparum
Drug: Sulfadoxine-pyrimethamine (Fansidar)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2004
Not Provided

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
Sexes Eligible for Study: All
up to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
 
NCT00137553
PSB-2001-Fansidar
No
Not Provided
Not Provided
Not Provided
Bandim Health Project
Not Provided
Study Director: Peter Aaby, Professor Bandim Health Project
Bandim Health Project
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP