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
  Purpose

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
Malaria

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Percentage of the parasites with mutations coding for resistance to antimalarials. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 600
Study Start Date: May 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01133314     History of Changes
Other Study ID Numbers: AL-eff 2010-2
Study First Received: May 24, 2010
Last Updated: March 16, 2013
Health Authority: Guinea-Bissau: Ministry of Health

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014