Artemether-Lumefantrine Effectiveness in Guinea-Bissau

The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum at the Bandim Health Centre

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.

Study Overview

• Status: Completed
• Conditions: Malaria

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
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Guinea-Bissau
  • Bissau Codex
    • Bissau, Bissau Codex, Guinea-Bissau, 1004
      • Bandim Health Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coartem, chloroquine, quinine; All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACPR 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.	day 42

Secondary Outcome Measures

Outcome Measure	Time Frame
ACPR day 28	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	All possible side effects will be recorded during the 42 day long follow-up.	During follow-up for 42 days

Collaborators and Investigators

• Sponsor: Bandim Health Project

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (Estimate): July 7, 2010

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: children; effectiveness; malaria; Guinea-Bissau; artemether; lumefantrine
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: AL-eff 2010