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Introducing Rapid Diagnostic Tests Into the Private Health Sector

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ClinicalTrials.gov Identifier: NCT01194557
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : October 12, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Fever Malaria Diagnosis Referral Device: Rapid diagnostic test Drug: Lumartem

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2010
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Appropriateness of treatment [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Appropriateness of referral of complicated malaria cases [ Time Frame: 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with fever
  • uncomplicted malaria

Exclusion Criteria:

  • Complicated malaria
  • known allergic reactions to Lumartem
Contacts and Locations

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): 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 Therapy
Investigators
Principal Investigator: Anthony K Mbonye, PhD Ministry of Health, Uganda
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012

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