The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
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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 |
- Re-appearing parasitaemia
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | March 2004 |
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 |
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 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 June 18, 2013