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CompletedNCT00137553Updated Mar 16, 2010

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

A Phase 4 interventional study of Sulfadoxine-pyrimethamine (Fansidar) in Malaria, Falciparum, sponsored by Bandim Health Project. Completed at 1 site in Guinea-Bissau. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2010-03-16.

Sponsored by Bandim Health Project · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
Up to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malaria, Falciparum

Keywords

  • Children
  • malaria
  • sulfadoxine-pyrimethamine
  • Guinea-Bissau
  • treatment
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 60 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Bandim Health Project is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
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

Exclusion Criteria:

  • Stated allergy to sulfadoxine and/or pyrimethamine
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants

Interventions

  • DrugSulfadoxine-pyrimethamine (Fansidar)
06

What researchers measure

Primary outcomes

  1. Re-appearing parasitaemia

07

Study locations

1 site
  • Bandim Health Project
    Apartado 861, Bissau, Guinea-Bissau
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00137553
Lead sponsor
Bandim Health Project
First posted
Aug 30, 2005
Start date
May 2001
Completion
Mar 2004
Last update
Mar 16, 2010

Study contacts

Peter Aaby, Professor
study director · Bandim Health Project

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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