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Clinical Trials/NCT01194557
NCT01194557CompletedNot Applicable

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

DBL -Institute for Health Research and Development1 site in 1 country2,600 target enrollmentStarted: September 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2,600
Locations
1
Primary Endpoint
Appropriateness of treatment

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Month to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with fever
  • uncomplicted malaria

Exclusion Criteria

  • Complicated malaria
  • known allergic reactions to Lumartem

Arms & Interventions

rapid diagnostic test

Active Comparator

Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests

Intervention: Rapid diagnostic test (Device)

rapid diagnostic test

Active Comparator

Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests

Intervention: Lumartem (Drug)

Outcomes

Primary Outcomes

Appropriateness of treatment

Time Frame: 36 months

Secondary Outcomes

  • Appropriateness of referral of complicated malaria cases(36 months)

Investigators

Sponsor
DBL -Institute for Health Research and Development
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pascal Magnussen

Senior Researcher

DBL -Institute for Health Research and Development

Study Sites (1)

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