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Parasite-based Diagnosis for Malaria in Uganda: Feasibility and Cost-Effectiveness

This study is currently recruiting participants.
Verified March 2012 by Makerere University
Sponsor:
Collaborator:
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Institute of Public Health, Makerere University
ClinicalTrials.gov Identifier:
NCT00565071
First received: November 28, 2007
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to compare the cost-effectiveness of treating malaria based on three methods of diagnosis (rapid test, microscopy and presumptive diagnosis) among patients attending level three government health centres located in areas of low and high transmission intensities in Uganda. The study hypotheses are: in both low and high transmission areas, cost-effectiveness of malaria treatment with Artemether-Lumefantrine will be improved by the adoption of rapid diagnostic tests when compared with presumptive diagnosis or microscopy; and the difference between the cost-effectiveness of Artemether-Lumefantrine treatment following rapid diagnostic test or microscopy versus presumptive diagnosis will be greatest in low transmission areas.


Condition Intervention
Fever
Malaria
 Device: Field microscopy and Paracheck Pf®

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Parasite-based Diagnosis for Malaria in Uganda: Feasibility and Cost-Effectiveness

Resource links provided by NLM:

MedlinePlus related topics: Fever Malaria
U.S. FDA Resources

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • diagnostic test validity; unit cost per malaria case diagnosed and treated with Artemether-Lumefantrine; total savings associated with treatment of confirmed malaria cases; compliance with directives for use of rapid test or microscopy [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • unit cost of non-malaria febrile treatment; therapeutic behaviour in light of pressure to prescribe antimalarials [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 102087
Study Start Date: October 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Field microscopy
Field microscopy is the main method of malaria diagnosis
 Device: Field microscopy and Paracheck Pf®
Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
Paracheck Pf® device
Paracheck Pf® device (Rapid Diagnostic Test) is the main method for malaria diagnosis
 Device: Field microscopy and Paracheck Pf®
Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
No Intervention: Presumptive diagnostic method

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected uncomplicated malaria infection
  • Consent to participate

Exclusion Criteria:

  • Pregnancy (policy recommends quinine for treatment of malaria in pregnancy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565071

Contacts
Contact: Vincent K. Batwala, MPH +256 712 074706 vbatwala@yahoo.com, vkbatwala@gmail.com
Contact: Fred Nuwaha, MD, PhD +256 782 518324 nuwahaf@yahoo.co.uk

Locations
Uganda
Bushenyi and Iganga districts - Government Health Cetres level III Recruiting
Bushenyi and Iganga, Uganda
Contact: Vincent K. Batwala, MPH     +256 712 074706     vbatwala@yahoo.com    
Contact: Fred Nuwaha, MD, PhD     +256 782 518324     nuwahaf@yahoo.co.uk    
Sponsors and Collaborators
Makerere University
Department for International Development, United Kingdom
Investigators
Study Chair: Fred Nuwaha, MD, PhD Department of Disease Control and Environmental Health, Makerere Universtiy School of Public Health
  More Information

No publications provided by Makerere University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Institute of Public Health, Prof. Fred Nuwaha, MD, PhD, Makerere University School of Public Health, Makerere University
ClinicalTrials.gov Identifier: NCT00565071     History of Changes
Other Study ID Numbers: 2006/HD20/4758U
Study First Received: November 28, 2007
Last Updated: March 27, 2012
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Cost-effectiveness
Diagnosis
Treatment
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 23, 2013