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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00137553
Other study ID # PSB-2001-Fansidar
Secondary ID
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
Est. primary completion date
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


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
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