Overview

This trial is active, not recruiting.

Condition malaria
Sponsor Bandim Health Project
Start date May 2010
End date December 2012
Trial size 600 participants
Trial identifier NCT01133314, AL-eff 2010-2

Summary

The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Percentage of children treated for malaria with a parasitological confirmed malaria.
time frame: 6 weeks

Secondary Outcomes

Measure
Percentage of the parasites with mutations coding for resistance to antimalarials.
time frame: 2 years

Eligibility Criteria

Male or female participants up to 15 years old.

Inclusion Criteria: - Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial. Exclusion Criteria: - Children where the parents do not accept to participate in the study.

Additional Information

Official title The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2
Principal investigator Poul-Erik Kofoed, MD, Ph.d.
Description Children from Bissau seeking medical advice and who are recommended treatment for malaria in accordance with the current routines will be included as follows: All children getting the clinical diagnosis of malaria will be registered and basic information collected. All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area. The study does not interfere in the routine treatment of the health staff. None of the children will be followed.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Bandim Health Project.