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

This study has been completed.
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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
Device: Rapid Diagnostic Test for P. falciparum malaria
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00549003

Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units
Zanzibar, Tanzania
Sponsors and Collaborators
Karolinska University Hospital
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 
Study First Received: October 24, 2007
Last Updated: October 24, 2007
Health Authority: Tanzania: Ministry of Health

Additional relevant MeSH terms:
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on May 01, 2016