Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2010-03-31
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Coartem, chloroquine, quinine
All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Having P. falciparum parasites in a thick film and/or a positive RDT
* The Bandim address is known (to enable follow up).
Exclusion Criteria
* Signs of severe malaria such as convulsion or severe anemia
15 Years
ALL
No
Sponsors
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Bandim Health Project
OTHER
Responsible Party
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Locations
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Bandim Health Project
Bissau, Bissau Codex, Guinea-Bissau
Countries
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References
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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.
Other Identifiers
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AL-eff 2010
Identifier Type: -
Identifier Source: org_study_id
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