Back to results

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

Primary Purpose

Malaria, Falciparum

Status

Completed

Phase

Phase 4

Locations

Guinea-Bissau

Study Type

Interventional

Intervention

Sulfadoxine-pyrimethamine (Fansidar)

About this trial

This is an interventional treatment trial for Malaria, Falciparum focused on measuring Children, malaria, sulfadoxine-pyrimethamine, Guinea-Bissau, treatment

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bandim Health Project

Outcomes

Primary Outcome Measures

Re-appearing parasitaemia

Secondary Outcome Measures

Full Information

NCT ID

NCT00137553

First Posted

August 28, 2005

Last Updated

March 15, 2010

Sponsor

Bandim Health Project

1. Study Identification

Unique Protocol Identification Number

NCT00137553

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

May 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Bandim Health Project

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria, Falciparum

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sulfadoxine-pyrimethamine (Fansidar)

Primary Outcome Measure Information:

Title

Re-appearing parasitaemia

10. Eligibility

Sex

All

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Aaby, Professor

Organizational Affiliation

Bandim Health Project

Official's Role

Study Director

Facility Information:

Facility Name

Bandim Health Project

City

Apartado 861

State/Province

Bissau

Country

Guinea-Bissau

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs