Introducing Rapid Diagnostic Tests Into the Private Health Sector

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Uganda
London School of Hygiene and Tropical Medicine
Artemisinin based combination Therapies Consortium
Information provided by (Responsible Party):
Pascal Magnussen, DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT01194557
First received: September 2, 2010
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.

This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug shops in an area with high malaria transmission.


Condition Intervention
Fever
Malaria
Diagnosis
Referral
Device: Rapid diagnostic test
Drug: Lumartem

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Introducing Rapid Diagnostic Tests Into the Private Health Sector in Uganda: a Randomised Trial Among Registered Drug Shops to Evaluate Impact on Antimalarial Drug Use

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

Primary Outcome Measures:
  • Appropriateness of treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appropriateness of referral of complicated malaria cases [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 2600
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rapid diagnostic test
Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests
Device: Rapid diagnostic test
Diagnosis of malaria using rapid diagnostic test
Drug: Lumartem
Presumptive treatment of malaria/fever
No Intervention: Presumptive malaria treatment
Presumptive treatment for malaria in drug shops

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with fever
  • uncomplicted malaria

Exclusion Criteria:

  • Complicated malaria
  • known allergic reactions to Lumartem
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01194557

Locations
Uganda
Mukono District
Mukono, Uganda
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Ministry of Health, Uganda
London School of Hygiene and Tropical Medicine
Artemisinin based combination Therapies Consortium
Investigators
Principal Investigator: Anthony K Mbonye, PhD Ministry of Health, Uganda
  More Information

Publications:
Responsible Party: Pascal Magnussen, Senior Researcher, DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier: NCT01194557     History of Changes
Other Study ID Numbers: ACTUGA3
Study First Received: September 2, 2010
Last Updated: October 11, 2012
Health Authority: United Kingdom: National Health Services

Keywords provided by DBL -Institute for Health Research and Development:
history of fever
measured fever
appropriate treatment
appropriate referral

Additional relevant MeSH terms:
Fever
Malaria
Body Temperature Changes
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014