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

This study has been completed.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00549003
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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
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.
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Karolinska University Hospital

Additional 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:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 28, 2014