NCT00549003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,346

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

October 24, 2007

Last Update Submit

October 24, 2007

Conditions

Malaria

Interventions

Rapid Diagnostic Test for P. falciparum malariaDEVICE
Also known as: Paracheck Pf, Manufactured by Orchid Biomedical Systems, Goa, INDIA.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient's refusal to consent will disqualify participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units

Zanzibar, Zanzibar, Tanzania

Location

Related Publications (1)

  • 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.

    PMID: 19399156DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPoint-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services Administration

Study Officials

  • Anders Björkman, MD,PhD

    Karolinska UH

    STUDY DIRECTOR

  • Mwinyi I Msellem, HLSO

    Karolinska UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

February 1, 2005

Study Completion

August 1, 2005

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations

TA(1)