TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT… (NCT06331364) | Clinical Trial Compass
RecruitingNot Applicable
TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial
Sri Lanka765 participantsStarted 2026-02-27
Plain-language 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).
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. Admitted within prior 48 hours
✓. Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following:
✓. New cough or sputum production
✓. Chest pain
✓. Dyspnea or tachypnea (respiratory rate \>20 breaths/minute)
✓. Abnormal lung examination
✓. Have evidence of acute infection, as indicated by at least one of the following:
✓. Self-reported fever or chills
Exclusion criteria
✕. Hospitalized recently (within last 28 days)
✕. If they have been enrolled into this clinical trial previously
✕. Surgery in the past 7 days
What they're measuring
1
Composite of adverse outcomes that could be attributed to withholding antibacterials
Timeframe: Day 30
2
Total duration of antibacterial prescription for the index visit
Timeframe: Index hospitalization, up to approximately 14 days