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

NCT ID: NCT00137553

Last Updated: 2010-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2004-03-31

Brief Summary

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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

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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.

Conditions

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Malaria, Falciparum

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sulfadoxine-pyrimethamine (Fansidar)

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bandim Health Project

OTHER

Sponsor Role lead

Principal Investigators

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Peter Aaby, Professor

Role: STUDY_DIRECTOR

Bandim Health Project

Locations

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Bandim Health Project

Apartado 861, Bissau Region, Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

Other Identifiers

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PSB-2001-Fansidar

Identifier Type: -

Identifier Source: org_study_id

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