NCT00153491

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Malaria, Uncomplicated

Keywords

malariaartemether-lumefantrineco-artemTanzaniaadherence

Interventions

artemether-lumefantrineDRUG

Eligibility Criteria

Age0 Years - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mkuranga District Hospital

Mkwanga, Mkuranga District, Tanzania

Location

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Louise Causer, MBBS, MScPH

    Centers for Disease Control and Prevention

    STUDY DIRECTOR

  • Salim Abdulla, MD, PhD

    Ifakara Health Research and Development Centre

    STUDY DIRECTOR

  • Peter B Bloland, DVM, MPVM

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Stephen P Kachur, MD, MPH

    Centers for Disease Control and Prevention

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2002

Study Completion

August 1, 2006

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

TA(1)