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

Malaria, Falciparum Clinical Trial

Official title:

The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137553
• Other study ID #: PSB-2001-Fansidar
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2005
• Last updated: March 15, 2010
• Start date: May 2001
• Est. completion date: March 2004

Study information

• Verified date: March 2010
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of HealthDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Sulfadoxine-pyrimethamine (Fansidar)

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Apartado 861	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-appearing parasitaemia