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ZRDT: Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar

Sponsor
Karolinska University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00549003
Collaborator
(none)
9,346
Enrollment
1
Location
5.9
Duration (Months)
1571.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.

Condition or Disease Intervention/Treatment Phase
  • Device: Rapid Diagnostic Test for P. falciparum malaria
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
9346 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Study Start Date :
Feb 1, 2005
Actual Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Any patient attending the study sites and reporting history of fever within past 48 hours or other symptoms compatible with malaria and giving their informed consent, will be eligible for the study.
    Exclusion Criteria:
    • Patient's refusal to consent will disqualify participation in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units Zanzibar Tanzania

    Sponsors and Collaborators

    • Karolinska University Hospital

    Investigators

    • Study Director: Anders Björkman, MD,PhD, Karolinska UH
    • Principal Investigator: Mwinyi I Msellem, HLSO, Karolinska UH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00549003
    Other Study ID Numbers:
    • ZRDT 2005
    First Posted:
    Oct 25, 2007
    Last Update Posted:
    Oct 25, 2007
    Last Verified:
    Oct 1, 2007
    Additional relevant MeSH terms:
    Malaria

    Study Results

    No Results Posted as of Oct 25, 2007