Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

NCT ID: NCT01133314

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Malaria

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Poul-Erik Kofoed, MD, Ph.d.

Role: PRINCIPAL_INVESTIGATOR

Bandim Health Project

Locations

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Bandim Health Project

Bissau, Bissau Codex, Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

Other Identifiers

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AL-eff 2010-2

Identifier Type: -

Identifier Source: org_study_id

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