Malaria, Uncomplicated Clinical Trial
Official title:
Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | August 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 59 Months |
| Eligibility |
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. |
Observational Model: Defined Population, Time Perspective: Longitudinal
| Country | Name | City | State |
|---|---|---|---|
| Tanzania | Mkuranga District Hospital | Mkuranga | Mkuranga District |
| Lead Sponsor | Collaborator |
|---|---|
| Centers for Disease Control and Prevention | Ifakara Health Research and Development Centre |
Tanzania,