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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Makerere University.
Recruitment status was  Recruiting
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
  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:


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

  Hide Detailed Description

Detailed Description:

The development of drug resistance in malaria parasites lead the Uganda Ministry of Health (MoH) to change the first-line anti-malarial treatment from the cheap Chloroquine/Sulfadoxine-Pyrimethamine combination to a more expensive Artemether-Lumefantrine. The MoH recommends treatment of all fever cases as malaria within 24 hours of illness with first-line drug. Under this policy, patients who do not have malaria but present with febrile illness will receive Coartem® resulting in significant drug wastage. With the increased cost of first-line drugs, this wastage places a substantial and potentially remediable burden on the health budget. As such, there is a need to gauge whether more accurate malaria diagnosis through microscopy and/or rapid diagnostic tests, might improve the cost-effectiveness of the new treatment regimes.

Specific objectives

  1. To assess the feasibility of rapid test and microscopy in diagnosis of malaria at health centre III.
  2. To compare the cost-effectiveness of treating malaria with Artemether- Lumefantrine based on microscopy, rapid test and presumptive diagnosis in different transmission intensities
  3. To assess whether introduction of malaria parasite-based diagnosis (rapid test or microscopy) at government Health Centre III improves the overall cost-effectiveness of outpatient management of febrile illness

Sample size determination The sample size was determined using standard formula. Estimating the sensitivity of either test to be 90%, Zα =1.96 and after stratifying for age (<5 years and ≥5 years), the calculated sample is 272 per health centre. Therefore, the total number of patients for 6 health centres in two districts = 6 x 272 = 1632.

Baseline: Baseline data was collected on the current malaria treatment practices; clinicians' view of malaria diagnosis; concerns towards the new treatment; and health centre staffing. Geographical locations of all visited government health centres was recorded using Germin etrex global positioning system (Germin International Inc., Olathe, USA). At six selected health centres, social and demographic data was collected from 613 patients.

Implementation of intervention: The main intervention is comprised of three malaria diagnostic approaches: presumptive diagnosis, field microscopy and rapid test (Paracheck Pf® device - Orchid Biomedical Systems, Goa, India). Each of these approaches was randomly allocated to a health centre. The first-line drug used is Artemether/Lumefantrine (20mg/120mg) (Novartis, Switzerland).

Consenting subjects are consecutively enrolled at the point when the attending clinician suspects that they have uncomplicated malaria. Where microscopy is the main diagnostic method, thick and thin blood smears are prepared per patient enrolled. Where rapid test is the main method, all patients are tested. One hundred patients per health centre are randomly selected to provide blood specimens for validation using expert microscopy and PCR as "gold standard." After enrolment, patients are systematically tracked until departure from the health centre. Patients are followed up on the seventh day of treatment to assess their clinical improvement. Those who fail to return on the scheduled date are traced from their homes on the eighth day.

Follow-up activities include: documentation of drugs prescribed and or dispensed; clinically assess the patient's status in comparison to Day 0; perform further tests including PCR if the patient does not show improvement; pill counting of drugs remaining - if the patient has not completed the dose; documentation of reasons for not completing dose; and documentation if the patient bought the prescribed drugs that were out of stock on Day 0.

Effectiveness is measured as the number of patients commencing treatment with Artemether/Lumefantrine. However, patients are followed up and effectiveness also measured on the 7th day of treatment indicated by their clinical improvement. The feasibility of the diagnostic methods is ongoing from the March 2010 to date.

  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 April 15, 2014