NCT00336388

Brief Summary

The purpose of this study is to investigate the impact of rapid diagnostic tests (RDTs) in the context of a newly implemented malaria case management guidelines using artemisinin-based combination therapy on the malaria prescribing practices of health care workers in Kenya.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

June 10, 2006

Last Update Submit

March 8, 2010

Conditions

Malaria

Keywords

Malaria

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of malaria diagnosis 6 weeks after the introduction of malaria rapid diagnostic tests

Secondary Outcomes (4)

  • Adherence to malaria case management guidelines by health care workers

  • Cost effectiveness of malaria case management guidelines using malaria rapid diagnostic tests

  • Acceptability of malaria rapid diagnostic tests to health care workers

  • Acceptability of malaria rapid diagnostic tests to patients

Interventions

Paracheck DeviceDEVICE

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All ill persons \>5 years old attending health facilities in Bondo and Kericho Districts, Kenya

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bondo and Kericho District Health Facilities

Kisumu, Nyanza Province, Kenya

Location

Related Publications (1)

  • Moody A. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev. 2002 Jan;15(1):66-78. doi: 10.1128/CMR.15.1.66-78.2002.

    PMID: 11781267BACKGROUND

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Mary Hamel, MD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Alexandre Macedo De Oliveira, MD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

June 10, 2006

First Posted

June 13, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

March 9, 2010

Record last verified: 2010-03

Locations

KE(1)