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

Primary Purpose

Uncomplicated Plasmodium Falciparum Malaria

Status
Completed
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
Rapid diagnostic test for malaria
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uncomplicated Plasmodium Falciparum Malaria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Villages

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Malaria diagnosis aided with rapid diagnostic test

Malaria diagnosis based on clinical judgement only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 8, 2006
Last Updated
October 31, 2007
Sponsor
Karolinska University Hospital
Collaborators
Muhimbili University of Health and Allied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00301015
Brief Title
Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers
Official Title
Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska University Hospital
Collaborators
Muhimbili University of Health and Allied Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Plasmodium Falciparum Malaria

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3005 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Malaria diagnosis aided with rapid diagnostic test
Arm Title
2
Arm Type
Active Comparator
Arm Description
Malaria diagnosis based on clinical judgement only
Intervention Type
Device
Intervention Name(s)
Rapid diagnostic test for malaria
Intervention Description
We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial
Primary Outcome Measure Information:
Title
Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups
Time Frame
28 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Björkman, MD, PhD
Organizational Affiliation
Dept of Medicine, Karolinska University Hospital, 171 76 Stockholm, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Villages
City
Kibaha
State/Province
Kibaha District
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
21750697
Citation
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.
Results Reference
derived

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

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