Artemether-Lumefantrine Effectiveness in Guinea-Bissau

• ClinicalTrials.gov Identifier: NCT01157689
• Recruitment Status: Completed
• First Posted: July 7, 2010
• Last Update Posted: May 19, 2021
• Sponsor: Bandim Health Project
• Information provided by (Responsible Party): Bandim Health Project

Tracking Information

• First Submitted Date: July 6, 2010
• First Posted Date: July 7, 2010
• Last Update Posted Date: May 19, 2021
• Actual Study Start Date: March 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2013)

ACPR day 42 [ Time Frame: day 42 ]

Malaria slides will be examined weekly during follow-up until day 42. The adequate clinical and parasitological cure rate will to calculated for day 42.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: March 16, 2013): ACPR day 28 [ Time Frame: 28 days ]
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: March 16, 2013)

Side effects [ Time Frame: During follow-up for 42 days ]

All possible side effects will be recorded during the 42 day long follow-up.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Artemether-Lumefantrine Effectiveness in Guinea-Bissau
• Official Title: The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum at the Bandim Health Centre
• 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 be included in a follow-up study. The genetic basis of the parasites for developing resistance will be examined. In case of reappearance of parasites the child will be re-treated following the guidelines of the national malaria programme.

Detailed Description

Children from the Bandim area in Bissau who are 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. Of theses, children fulfilling the inclusion criteria will be included in a follow-up study.

The children included in the follow-up part of the study will be visited on day 7, day 14, day 21, day 28, day 35 and day 42. At each visit the condition of the child will be evaluated, a questionnaire will be filled in and a malaria film and approximately 100 µl blood on filter-paper (for PCR analysis in case of re-parasitaemia) will be taken. Furthermore, on day seven 100 μl blood on filter-paper will be taken for drug-analysis.

Children with parasitaemia detected by only one of the following methods will be excluded from the final analyses of the effectiveness: 1) malaria film, 2) RDT, and 3) PCR.

If the parents do not ensure that the children get the correct medication resulting in a high rate of recrudescence and/or a low drug-concentration on day seven the policy of the National Malaria Programme should be re-evaluated. If the health staff do not follow the guidelines of the National Malaria Programme the reasons why should be elucidated in order to ensure a better adherence.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Capillary blood samples for drug concentration analysis and for PCR for identifying the malaria parasites

• Sampling Method: Non-Probability Sample
• Study Population: Children diagnosed as having malaria at Bandim Health Center in Bissau. Of these all children with a positive malaria film and/or a positive rapid diagnostic test will be included in an observational follow-up study.
• Condition: Malaria
• Intervention: Not Provided

Study Groups/Cohorts

Coartem, chloroquine, quinine

All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff.

• Publications *: Jovel IT, Kofoed PE, Rombo L, Rodrigues A, Ursing J. Temporal and seasonal changes of genetic polymorphisms associated with altered drug susceptibility to chloroquine, lumefantrine, and quinine in Guinea-Bissau between 2003 and 2012. Antimicrob Agents Chemother. 2015 Feb;59(2):872-9. doi: 10.1128/AAC.03554-14. Epub 2014 Nov 24.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 6, 2010): 500
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Prescribed an anti-malarial at the Bandim Health Centre
• Having P. falciparum parasites in a thick film and/or a positive RDT
• The Bandim address is known (to enable follow up).

Exclusion Criteria:

• Children where the parents do not accept to participate in the study.
• Signs of severe malaria such as convulsion or severe anemia

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 15 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Guinea-Bissau

Administrative Information

• NCT Number: NCT01157689
• Other Study ID Numbers: AL-eff 2010
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bandim Health Project
• Original Responsible Party: Dr. Poul-Erik Kofoed, Bandim Health Project
• Current Study Sponsor: Bandim Health Project
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bandim Health Project
• Verification Date: May 2021