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Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01133314
First received: May 24, 2010
Last updated: March 16, 2013
Last verified: November 2012
History of Changes

May 24, 2010
March 16, 2013
May 2010
December 2012   (final data collection date for primary outcome measure)
Percentage of children treated for malaria with a parasitological confirmed malaria. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Percentage of children treated for malaria with a parasitological confirmed malaria. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01133314 on ClinicalTrials.gov Archive Site
Percentage of the parasites with mutations coding for resistance to antimalarials. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2
The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in 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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.
Non-Probability Sample

Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Malaria
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
March 2014
December 2012   (final data collection date for primary outcome measure)

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.
Both
up to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
NCT01133314
AL-eff 2010-2
No
Bandim Health Project
Bandim Health Project
Not Provided
Principal Investigator: Poul-Erik Kofoed, MD, Ph.d. Bandim Health Project
Bandim Health Project
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP