Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2
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Purpose
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 have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.
| Condition |
|---|
|
Malaria |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2 |
- Percentage of children treated for malaria with a parasitological confirmed malaria. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The blood samples will be analysed for parasites at the end of the study. The results do not have any impact on the treatment of the children.
- Percentage of the parasites with mutations coding for resistance to antimalarials. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
App 50 - 100 microliters blood on filterpaper for identification of parasite. Furthermore, whenever the health staff use a RDT this will be saved for the same analyses.
| Estimated Enrollment: | 600 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | March 2014 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Children from Bissau 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.
All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area.
The study does not interfere in the routine treatment of the health staff. None of the children will be followed.
Eligibility| Ages Eligible for Study: | up to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Inclusion Criteria:
- Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Exclusion Criteria:
- Children where the parents do not accept to participate in the study.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Bandim Health Project |
| ClinicalTrials.gov Identifier: | NCT01133314 History of Changes |
| Other Study ID Numbers: | AL-eff 2010-2 |
| Study First Received: | May 24, 2010 |
| Last Updated: | March 16, 2013 |
| Health Authority: | Guinea-Bissau: Ministry of Health |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Artemether-lumefantrine combination Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013