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

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00301015
• Collaborator: Muhimbili University of Health and Allied Sciences (Other)
• Enrollment: 3,005
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 597.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Plasmodium Falciparum Malaria	Device: Rapid diagnostic test for malaria	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 3005 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Malaria diagnosis aided with rapid diagnostic test	Device: Rapid diagnostic test for malaria; We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial
Active Comparator: 2 Malaria diagnosis based on clinical judgement only	Device: Rapid diagnostic test for malaria; We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial

Outcome Measures

Primary Outcome Measures

1. Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Villages	Kibaha	Kibaha District	Tanzania

Sponsors and Collaborators

• Karolinska University Hospital
• Muhimbili University of Health and Allied Sciences

Investigators

• Study Director: Anders Björkman, MD, PhD, Dept of Medicine, Karolinska University Hospital, 171 76 Stockholm, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00301015
• Other Study ID Numbers: RapAct 28-02-2006
• First Posted: Mar 10, 2006
• Last Update Posted: Nov 1, 2007
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: Malaria; Malaria, Falciparum

Study Results

No Results Posted as of Nov 1, 2007