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

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ClinicalTrials.gov Identifier: NCT00549003
Recruitment Status : Completed
First Posted : October 25, 2007
Last Update Posted : October 25, 2007
Sponsor:
Information provided by:
Karolinska University Hospital

Study Description
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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
Malaria Device: Rapid Diagnostic Test for P. falciparum malaria Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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Intervention Details:
  • Device: Rapid Diagnostic Test for P. falciparum malaria
    Other Name: Paracheck Pf, Manufactured by Orchid Biomedical Systems, Goa, INDIA.

Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Tanzania
Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units
Zanzibar, Tanzania
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Study Director: Anders Björkman, MD,PhD Karolinska UH
Principal Investigator: Mwinyi I Msellem, HLSO Karolinska UH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00549003    
Other Study ID Numbers: ZRDT 2005
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases