Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
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

Tracking Information
First Submitted Date  ICMJE October 24, 2007
First Posted Date  ICMJE October 25, 2007
Last Update Posted Date October 25, 2007
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Official Title  ICMJE Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Malaria
Intervention  ICMJE Device: Rapid Diagnostic Test for P. falciparum malaria
Other Name: Paracheck Pf, Manufactured by Orchid Biomedical Systems, Goa, INDIA.
Study Arms  ICMJE Not Provided
Publications * Msellem MI, Mårtensson A, Rotllant G, Bhattarai A, Strömberg J, Kahigwa E, Garcia M, Petzold M, Olumese P, Ali A, Björkman 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October¬†24,¬†2007)
9346
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00549003
Other Study ID Numbers  ICMJE ZRDT 2005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anders Björkman, MD,PhD Karolinska UH
Principal Investigator: Mwinyi I Msellem, HLSO Karolinska UH
PRS Account Karolinska University Hospital
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP