Back to resultsEfficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar (ZRDT)
Primary Purpose
Malaria
Status
Completed
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
Rapid Diagnostic Test for P. falciparum malaria
Sponsored by
About this trial
This is an interventional diagnostic trial for Malaria
Eligibility 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.
Sites / Locations
- Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00549003
First Posted
October 24, 2007
Last Updated
October 24, 2007
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00549003
Brief Title
Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Acronym
ZRDT
Official Title
Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9346 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Rapid Diagnostic Test for P. falciparum malaria
Other Intervention Name(s)
Paracheck Pf, Manufactured by Orchid Biomedical Systems, Goa, INDIA.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Björkman, MD,PhD
Organizational Affiliation
Karolinska UH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mwinyi I Msellem, HLSO
Organizational Affiliation
Karolinska UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units
City
Zanzibar
Country
Tanzania
12. IPD Sharing Statement
Citations:
PubMed Identifier
19399156
Citation
Msellem MI, Martensson A, Rotllant G, Bhattarai A, Stromberg J, Kahigwa E, Garcia M, Petzold M, Olumese P, Ali A, Bjorkman A. Influence of rapid malaria diagnostic tests on treatment and health outcome in fever patients, Zanzibar: a crossover validation study. PLoS Med. 2009 Apr 28;6(4):e1000070. doi: 10.1371/journal.pmed.1000070. Epub 2009 Apr 28.
Results Reference
derived
Learn more about this trial
Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
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