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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549003
First Posted: October 25, 2007
Last Update Posted: October 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karolinska University Hospital
  Purpose
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 Intervention Phase
Malaria Device: Rapid Diagnostic Test for P. falciparum malaria Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Enrollment: 9346
Study Start Date: February 2005
Study Completion Date: August 2005
Intervention Details:
    Device: Rapid Diagnostic Test for P. falciparum malaria
    Other Name: Paracheck Pf, Manufactured by Orchid Biomedical Systems, Goa, INDIA.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549003


Locations
Tanzania
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00549003     History of Changes
Other Study ID Numbers: ZRDT 2005
First Submitted: October 24, 2007
First Posted: October 25, 2007
Last Update Posted: October 25, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases