Artemether-Lumefantrine Effectiveness in Guinea-Bissau
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|ClinicalTrials.gov Identifier: NCT01157689|
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : May 19, 2021
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|Condition or disease|
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|
|Estimated Enrollment :||500 participants|
|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|
Coartem, chloroquine, quinine
All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff.
- 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.
- ACPR day 28 [ Time Frame: 28 days ]
- 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
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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|
- 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).
- Children where the parents do not accept to participate in the study.
- Signs of severe malaria such as convulsion or severe anemia
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
|Bandim Health Project|
|Bissau, Bissau Codex, Guinea-Bissau, 1004|
|Responsible Party:||Bandim Health Project|
|Other Study ID Numbers:||
|First Posted:||July 7, 2010 Key Record Dates|
|Last Update Posted:||May 19, 2021|
|Last Verified:||May 2021|
Vector Borne Diseases