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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
Sponsor:
Information provided by (Responsible Party):
Bandim Health Project

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum at the Bandim Health Centre
Actual Study Start Date : March 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ACPR day 28 [ Time Frame: 28 days ]

Other Outcome Measures:
  1. Side effects [ Time Frame: During follow-up for 42 days ]
    All possible side effects will be recorded during the 42 day long follow-up.


Biospecimen Retention:   Samples Without DNA
Capillary blood samples for drug concentration analysis and for PCR for identifying the malaria parasites

Eligibility Criteria
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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157689


Locations
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Guinea-Bissau
Bandim Health Project
Bissau, Bissau Codex, Guinea-Bissau, 1004
Sponsors and Collaborators
Bandim Health Project
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01157689    
Other Study ID Numbers: AL-eff 2010
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Keywords provided by Bandim Health Project:
malaria
children
Guinea-Bissau
 artemether
lumefantrine
effectiveness
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases