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

Malaria Clinical Trial

— ZRDT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549003
• Other study ID #: ZRDT 2005
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2007
• Last updated: October 24, 2007
• Start date: February 2005
• Est. completion date: August 2005

Study information

• Verified date: October 2007
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9346
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malaria

Intervention

Device:
• Rapid Diagnostic Test for P. falciparum malaria

Locations

Country	Name	City	State
Tanzania	Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units	Zanzibar

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Tanzania,