Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

NCT ID: NCT00301015

Last Updated: 2007-11-01

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

3005 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-08-31

Brief Summary

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The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs.

The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.

Detailed Description

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Conditions

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Uncomplicated Plasmodium Falciparum Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Malaria diagnosis aided with rapid diagnostic test

Group Type EXPERIMENTAL

Rapid diagnostic test for malaria

Intervention Type DEVICE

We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial

2

Malaria diagnosis based on clinical judgement only

Group Type ACTIVE_COMPARATOR

Rapid diagnostic test for malaria

Intervention Type DEVICE

We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial

Interventions

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Rapid diagnostic test for malaria

We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Fever
* Informed consent

Exclusion Criteria

* Severe clinical manifestations, which require immediate referral
* Pregnancy
* Previous enrollment in the study within the last 28 days
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Anders Björkman, MD, PhD

Role: STUDY_DIRECTOR

Dept of Medicine, Karolinska University Hospital, 171 76 Stockholm, Sweden

Locations

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Villages

Kibaha, Kibaha District, Tanzania

Site Status

Countries

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Tanzania

References

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Mubi M, Janson A, Warsame M, Martensson A, Kallander K, Petzold MG, Ngasala B, Maganga G, Gustafsson LL, Massele A, Tomson G, Premji Z, Bjorkman A. Malaria rapid testing by community health workers is effective and safe for targeting malaria treatment: randomised cross-over trial in Tanzania. PLoS One. 2011;6(7):e19753. doi: 10.1371/journal.pone.0019753. Epub 2011 Jul 5.

Reference Type DERIVED
PMID: 21750697 (View on PubMed)

Other Identifiers

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RapAct 28-02-2006

Identifier Type: -

Identifier Source: org_study_id