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The Efficacy of Re-Treatment with Sulfadoxine-Pyrimethamine in Children. - Article


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Pyrimethamine

Daraprim



Clinical Trial: The Efficacy of Re-Treatment with Sulfadoxine-Pyrimethamine in Children.

This study is no longer recruiting patients.

Sponsored by: Bandim Health Project
Information provided by: Bandim Health Project
ClinicalTrials.gov Identifier: NCT00137553

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 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 IV

MedlinePlus related topics:  Malaria

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Official Title: The Efficacy of Re-Treatment with Sulfadoxine-Pyrimethamine in Children with Recrudescent Malaria in Guinea-Bissau.

Further Study Details: 
Primary Outcomes: Re-appearing parasitaemia
Expected Total Enrollment:  60

Study start: May 2001;  Study completion: December 2005
Last follow-up: March 2004;  Data entry closure: August 2005

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 paracetaemia 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
Criteria

Inclusion Criteria:

Malaria symptoms plus positive malaria film > 20 parasites per 200 leukocytes treatment failure in a study comparing chloroquine and amodiaquine informed concent -

Exclusion Criteria:

stated allery to sulfadoxine and/or pyrimethamine

-

Location Information


Guinea-Bissau, Bissau
      Bandim Health Project, Apartado 861,  Bissau,  Guinea-Bissau

Study chairs or principal investigators

Peter Aaby, Professor,  Study Director,  Bandim Health Project   

More Information

Study ID Numbers:  PSB-2001-Fansidar
Last Updated:  August 29, 2005
Record first received:  August 28, 2005
ClinicalTrials.gov Identifier:  NCT00137553
Health Authority: Guinea-Bissau: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13

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November 18, 2008



Page Updated: June 1, 2005
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