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Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

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ClinicalTrials.gov Identifier: NCT01133314
Recruitment Status : Unknown
Verified November 2012 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
First Posted : May 28, 2010
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):

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
Malaria

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
Estimated 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 2010
Primary Completion Date : December 2012
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Percentage of children treated for malaria with a parasitological confirmed malaria. [ Time Frame: 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. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
App 50 - 100 microliters blood on filterpaper for identification of parasite. Furthermore, whenever the health staff use a RDT this will be saved for the same analyses.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133314


Locations
Guinea-Bissau
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
More Information

Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01133314     History of Changes
Other Study ID Numbers: AL-eff 2010-2
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: November 2012