Adherence to Lumefantrine-Artemether
This study has been completed.
Sponsor:
Collaborator:
Ifakara Health Research and Development Centre
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153491
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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Purpose
This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria, Uncomplicated |
Drug: artemether-lumefantrine |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Eligibility| Ages Eligible for Study: | up to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- age < 5 years of age.
- axillary temperature >= 37.5oC
- unmixed infection with P. falciparum of between 1,000 and 250,000 asexual parasites/mm3 as determined by microscopic examination of thick, or thick and thin peripheral blood smears.
- parent/guardian's informed consent and willingness to participate in the study
Exclusion criteria:
- any evidence of severe or complicated malaria that would require hospitalization for treatment.
- reported allergy to any antimalarial drugs, including artemisinin derivatives and sulfa drugs.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153491
Locations
| Tanzania | |
| Mkuranga District Hospital | |
| Mkuranga, Mkuranga District, Tanzania | |
Sponsors and Collaborators
Ifakara Health Research and Development Centre
Investigators
| Study Director: | Louise Causer, MBBS, MScPH | Centers for Disease Control and Prevention |
| Study Director: | Salim Abdulla, MD, PhD | Ifakara Health Research and Development Centre |
| Principal Investigator: | Peter B Bloland, DVM, MPVM | Centers for Disease Control and Prevention |
| Study Director: | Stephen P Kachur, MD, MPH | Centers for Disease Control and Prevention |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00153491 History of Changes |
| Other Study ID Numbers: | CDC-NCID-3602 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| Health Authority: | United States: Federal Government Tanzania: National Institute for Medical Research |
Keywords provided by Centers for Disease Control and Prevention:
|
malaria artemether-lumefantrine co-artem Tanzania adherence |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Artemether Artemisinins Lumefantrine Artemether-lumefantrine combination Antifungal Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics |
ClinicalTrials.gov processed this record on May 19, 2013