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Completed

NCT Number: NCT01133314

Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandim Health Project

Bissau, Bissau Codex, Guinea-Bissau

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Percentage of the parasites with mutations coding for resistance to antimalarials.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2016
First posted
May 28, 2010
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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