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TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial
Sponsor: Duke University
Summary
This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka. The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group. The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed (a maximum of 14 days).
Official title: TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): A Stepped-wedge Cluster Randomized Trial of an Electronic Clinical Decision Support Tool (eCDST) for the Diagnosis and Treatment of Lower Respiratory Tract Infection (LRTI) in Selected Hospitals in Southern Sri Lanka
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
765
Start Date
2026-02-27
Completion Date
2028-02
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
electronic clinical decision support tool (eCDST) diagnostic plan
Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials used. Analyses will compare clinical outcomes and antimicrobial use between the intervention arm and usual care.
Locations (3)
Base Hospital Balapitiya
Balapitiya, Sri Lanka
Galle National Hospital
Karapitiya, Sri Lanka
District General Hospital Matara
Matara, Sri Lanka