Artemether-Lumefantrine Effectiveness in Guinea-Bissau
Recruitment status was Active, not recruiting
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 Design:||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|
- ACPR day 42 [ Time Frame: day 42 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: During follow-up for 42 days ] [ Designated as safety issue: Yes ]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
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Coartem, chloroquine, quinine
All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157689
|Bandim Health Project|
|Bissau, Bissau Codex, Guinea-Bissau, 1004|