Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

Completed

• Conditions: Malaria

• Registration Number: NCT01133314
• Lead Sponsor: Bandim Health Project

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2012-12
• Status Verified: 2015-08
• Study Completion: 2016-07
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of children treated for malaria with a parasitological confirmed malaria.	6 weeks	The blood samples will be analysed for parasites at the end of the study. The results do not have any impact on the treatment of the children.

Secondary Outcome Measures

Name	Time	Method
Percentage of the parasites with mutations coding for resistance to antimalarials.	2 years

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Bissau Codex, Guinea-Bissau