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Artemether-Lumefantrine Effectiveness in Guinea-Bissau

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01157689
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : May 19, 2021
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
Change History
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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: July 6, 2010)
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
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
Removed Location Countries  
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