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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00137553
Enrollment
60
Registered
2005-08-30
Start date
2001-05-31
Completion date
2004-03-31
Last updated
2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Falciparum

Keywords

Children, malaria, sulfadoxine-pyrimethamine, Guinea-Bissau, treatment

Brief summary

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.

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.

Interventions

Sponsors

Bandim Health Project
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
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

Design outcomes

Primary

MeasureTime frame
Re-appearing parasitaemia

Countries

Guinea-Bissau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026