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

Phase 4

Completed

• Conditions: Uncomplicated Plasmodium Falciparum Malaria
• Interventions: Device: Rapid diagnostic test for malaria

• Registration Number: NCT00301015
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-10
• Study Completion: 2006-08
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-31
• Last Update Posted: 2007-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3005

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Rapid diagnostic test for malaria	Malaria diagnosis aided with rapid diagnostic test
2	Rapid diagnostic test for malaria	Malaria diagnosis based on clinical judgement only

Primary Outcome Measures

Name	Time	Method
Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups	28 days

Trial Locations

Locations (1)

Villages; 🇹🇿 Kibaha, Kibaha District, Tanzania