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:

MedlinePlus related topics: Malaria

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:


Enrollment:	9346
Study Start Date:	February 2005
Study Completion Date:	August 2005

Intervention Details:

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):

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.


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 Parasitic Diseases Protozoan Infections

ClinicalTrials.gov processed this record on March 01, 2015

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