NCT00301015

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,005

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

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

March 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

March 8, 2006

Last Update Submit

October 31, 2007

Conditions

Uncomplicated Plasmodium Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

  • Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups

    28 days

Study Arms (2)

1

EXPERIMENTAL

Malaria diagnosis aided with rapid diagnostic test

Device: Rapid diagnostic test for malaria

2

ACTIVE COMPARATOR

Malaria diagnosis based on clinical judgement only

Device: Rapid diagnostic test for malaria

Interventions

Rapid diagnostic test for malariaDEVICE

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

12

Eligibility Criteria

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

You may qualify if:

  • Fever
  • Informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villages

Kibaha, Kibaha District, Tanzania

Location

Related Publications (1)

  • 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.

    PMID: 21750697DERIVED

MeSH Terms

Interventions

Rapid Diagnostic Tests

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

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

    STUDY DIRECTOR

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

March 8, 2006

First Posted

March 10, 2006

Study Start

March 1, 2006

Study Completion

August 1, 2006

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

TA(1)