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

Sponsor

Bandim Health Project (Other)

Overall Status

Completed

CT.gov ID

NCT00137553

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria, Falciparum	Drug: Sulfadoxine-pyrimethamine (Fansidar)	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2001

Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Re-appearing parasitaemia []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 15 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bandim Health Project	Apartado 861	Bissau	Guinea-Bissau

Sponsors and Collaborators

Bandim Health Project

Investigators

Study Director: Peter Aaby, Professor, Bandim Health Project

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00137553

Other Study ID Numbers:

PSB-2001-Fansidar

First Posted:

Aug 30, 2005

Last Update Posted:

Mar 16, 2010

Last Verified:

Mar 1, 2010

Keywords provided by , ,

Children

malaria

sulfadoxine-pyrimethamine

Guinea-Bissau

treatment

Additional relevant MeSH terms:

Fanasil, pyrimethamine drug combination

Study Results

No Results Posted as of Mar 16, 2010