NCT00115921

Brief Summary

The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2005

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

June 26, 2005

Last Update Submit

January 11, 2017

Conditions

MalariaAnemia

Keywords

Home-based careMalariaAfrica

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.

Secondary Outcomes (7)

  • Mean days of fever per participant

  • Incidence of febrile episodes

  • Mean haemoglobin at study end

  • Change in mean haemoglobin between the start and end of the intervention

  • Incidence of visits to health care facilities (drug shops, clinics, pharmacies, hospitals) and hospitalizations per participant

  • +2 more secondary outcomes

Interventions

Provision of antimalarial treatment at homeBEHAVIORAL

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1 - 5 years
  • Agreement of parents or guardians to provide informed consent
  • Live in Mulago III Parish

You may not qualify if:

  • History of any known serious chronic disease requiring frequent medical care (e.g. AIDS, sickle cell disease, malignancy)
  • Intention to move from Kampala during the 13 month follow-up period
  • History of serious side effects to study medications
  • Weight \< 10 kg
  • Severe malnutrition defined as a weight-for-height or height-for-age Z-score \< - 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Staedke SG, Mwebaza N, Kamya MR, Clark TD, Dorsey G, Rosenthal PJ, Whitty CJ. Home management of malaria with artemether-lumefantrine compared with standard care in urban Ugandan children: a randomised controlled trial. Lancet. 2009 May 9;373(9675):1623-31. doi: 10.1016/S0140-6736(09)60328-7. Epub 2009 Apr 9.

    PMID: 19362361DERIVED

MeSH Terms

Conditions

MalariaAnemia

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sarah G Staedke, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Christopher JM Whitty, FRCP

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

July 1, 2005

Study Completion

April 1, 2007

Last Updated

January 12, 2017

Record last verified: 2017-01