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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-08-31

Brief Summary

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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

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Rapid Diagnostic Test for P. falciparum malaria

Intervention Type DEVICE

Other Intervention Names

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Paracheck Pf, Manufactured by Orchid Biomedical Systems, Goa, INDIA.

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Björkman, MD,PhD

Role: STUDY_DIRECTOR

Karolinska UH

Mwinyi I Msellem, HLSO

Role: PRINCIPAL_INVESTIGATOR

Karolinska UH

Locations

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Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units

Zanzibar, Zanzibar, Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED

PMID: 19399156 (View on PubMed)

Other Identifiers

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ZRDT 2005

Identifier Type: -

Identifier Source: org_study_id