Pyrimethamine |
Daraprim |
Clinical Trial: The Efficacy of Re-Treatment with Sulfadoxine-Pyrimethamine in Children.
This study is no longer recruiting patients.
|
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.
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
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
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Location Information
Guinea-Bissau, Bissau
Bandim Health Project, Apartado 861, Bissau, Guinea-Bissau
Peter Aaby, Professor, Study Director, Bandim Health Project
More Information
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
Resources
- Daraprim (Drug Digest)
- Pyrimethamine (Drug Digest)

Not Signed In -


