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Adherence to Lumefantrine-Artemether

NCT ID: NCT00153491

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria, Uncomplicated

Keywords

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malaria artemether-lumefantrine co-artem Tanzania adherence

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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artemether-lumefantrine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ifakara Health Research and Development Centre

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Louise Causer, MBBS, MScPH

Role: STUDY_DIRECTOR

Centers for Disease Control and Prevention

Salim Abdulla, MD, PhD

Role: STUDY_DIRECTOR

Ifakara Health Research and Development Centre

Peter B Bloland, DVM, MPVM

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Stephen P Kachur, MD, MPH

Role: STUDY_DIRECTOR

Centers for Disease Control and Prevention

Locations

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Mkuranga District Hospital

Mkwanga, Mkuranga District, Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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CDC-NCID-3602

Identifier Type: -

Identifier Source: org_study_id