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

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00301015
First received: March 8, 2006
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Uncomplicated Plasmodium Falciparum Malaria
Device: Rapid diagnostic test for malaria
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups [ Time Frame: 28 days ]

Enrollment: 3005
Study Start Date: March 2006
Study Completion Date: August 2006
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301015

Locations
Tanzania
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
  More Information

No publications provided by Karolinska University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00301015     History of Changes
Other Study ID Numbers: RapAct 28-02-2006
Study First Received: March 8, 2006
Last Updated: October 31, 2007
Health Authority: Tanzania: Ministry of Health
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Artemisinins
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014