Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

Malaria Clinical Trial

Official title:

The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133314
• Other study ID #: AL-eff 2010-2
• Status: Completed
• Start date: May 2010
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau	Bissau Codex

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of children treated for malaria with a parasitological confirmed malaria.	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.	6 weeks
Secondary	Percentage of the parasites with mutations coding for resistance to antimalarials.		2 years