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Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

Sponsor
Bandim Health Project (Other)
Overall Status
Completed
CT.gov ID
NCT01133314
Collaborator
(none)
600
Enrollment
1
Location
74
Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    600 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Percentage of the parasites with mutations coding for resistance to antimalarials. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Bandim Health Project

    Investigators

    • Principal Investigator: Poul-Erik Kofoed, MD, Ph.d., Bandim Health Project

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bandim Health Project
    ClinicalTrials.gov Identifier:
    NCT01133314
    Other Study ID Numbers:
    • AL-eff 2010-2
    First Posted:
    May 28, 2010
    Last Update Posted:
    May 26, 2021
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Malaria

    Study Results

    No Results Posted as of May 26, 2021