Actively Recruiting
TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial
Led by Duke University · Updated on 2026-03-16
765
Participants Needed
3
Research Sites
100 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to the hospital within the prior 48 hours
- Evidence of new acute respiratory illness lasting less than 14 days with at least one of the following: new cough or sputum, chest pain, difficulty breathing or rapid breathing (over 20 breaths per minute), abnormal lung exam
- Evidence of acute infection shown by at least one of: self-reported fever or chills, fever of 38°C (100.4°F) or higher, hypothermia below 35.5°C (95.9°F), high white blood cell count over 10,000/mm3, low white blood cell count below 3,000/mm3, or new altered mental status
- Patient, parent, or legally authorized representative can give informed consent
- Children aged 14-17 years can provide assent
- Ability to complete a follow-up visit at 30 days either in person or by phone
You will not qualify if you...
- Hospitalized within the last 28 days
- Previously enrolled in this clinical trial
- Surgery within the past 7 days
- Unable or unwilling to complete the 30-day follow-up
- Likely to be transferred from the medical ward within 24 hours of enrollment
- Conditions where doctors would not withhold antibacterial treatment, including: vasopressor therapy, cystic fibrosis, severe immunosuppression (such as cancer with low neutrophils, recent transplant, active graft-versus-host disease, chronic steroids or other immune suppressants, HIV with low CD4 count)
- Having a non-respiratory infection at the time of enrollment
- Evidence of lung abscess or empyema
- Respiratory failure requiring invasive or non-invasive ventilation at enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Base Hospital Balapitiya
Balapitiya, Sri Lanka
Actively Recruiting
2
Galle National Hospital
Karapitiya, Sri Lanka
Actively Recruiting
3
District General Hospital Matara
Matara, Sri Lanka
Actively Recruiting
Research Team
G
Gayani Tillekeratne, MD, MSc
CONTACT
S
Stefany Olague, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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