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

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ClinicalTrials.gov Identifier: NCT00565071
Recruitment Status : Unknown
Verified March 2012 by Institute of Public Health, Makerere University.
Recruitment status was:  Recruiting
First Posted : November 29, 2007
Last Update Posted : March 28, 2012
Sponsor:
Collaborator:
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Institute of Public Health, Makerere University

Brief Summary:
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 or disease Intervention/treatment Phase
Fever Malaria Device: Field microscopy and Paracheck Pf® Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102087 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Parasite-based Diagnosis for Malaria in Uganda: Feasibility and Cost-Effectiveness
Study Start Date : October 2006
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. unit cost of non-malaria febrile treatment; therapeutic behaviour in light of pressure to prescribe antimalarials [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Institute of Public Health, Makerere University:
Cost-effectiveness
Diagnosis
Treatment
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases