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

Karolinska University Hospital

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Device: Rapid Diagnostic Test for P. falciparum malaria

Study type: Interventional

Funder types: Other

Identifiers

NCT00549003

ZRDT 2005

Details and patient eligibility

About

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.

Enrollment: 9,346 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)