Electronic decision tool for treating lower respiratory infections in Southern Sri Lanka

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

This trial will test an electronic clinical decision support tool to help clinicians diagnose and guide antibiotic use for people 14 and older admitted with new lower respiratory infections at three hospitals in Southern Sri Lanka.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 765 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Duke University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 3 sites (Balapitiya and 2 other locations)
• Trial ID: NCT06331364 on ClinicalTrials.gov

What this trial studies

This is a stepped-wedge, cluster-randomized, open-label two-arm trial that introduces an electronic clinical decision support tool (eCDST) on medical wards at three hospitals in Southern Province, Sri Lanka. Medical wards are randomized in clusters and cross over to the eCDST intervention at intervals of 3–6 months until all wards have implemented the tool, enrolling a total of 765 patients aged 14 years and older. Participants admitted within 48 hours with new respiratory symptoms and objective signs of infection will be followed for 30 days to record clinical outcomes and any antibacterial prescriptions (up to 14 days). The primary comparison is clinical outcomes and antibiotic prescribing in patients cared for with the eCDST versus usual care.

Who should consider this trial

Good fit: Patients aged 14 years or older admitted within 48 hours with new (≤14 days) lower respiratory symptoms and evidence of acute infection, who can provide consent/assent and complete 30-day follow-up, are ideal candidates.

Not a fit: Patients recently hospitalized, with symptoms longer than 14 days, unable to consent or complete follow-up, or treated outside the enrolled wards are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the tool could reduce unnecessary antibiotic use and improve patient outcomes by helping clinicians make more targeted diagnostic and treatment decisions for lower respiratory infections.

How similar studies have performed: Electronic decision-support and antibiotic stewardship interventions have reduced inappropriate antibiotic prescribing in other settings, though results vary and stepped-wedge implementation in low-resource hospitals is less well studied.

Eligibility criteria

Inclusion Criteria:

1. Admitted within prior 48 hours
2. Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following:

   1. New cough or sputum production
   2. Chest pain
   3. Dyspnea or tachypnea (respiratory rate \>20 breaths/minute)
   4. Abnormal lung examination
3. Have evidence of acute infection, as indicated by at least one of the following:

   1. Self-reported fever or chills
   2. Documented fever ≥38 ̊ C (100.4 ̊ F)
   3. Documented hypothermia \<35.5 ̊ C (95.9 ̊ F)
   4. Leukocytosis (white blood cell count \>10,000/mm3)
   5. Leukopenia (white blood cell count \<3000/mm3)
   6. New altered mental status
4. Ability and willingness of patient, parent or legally authorized representative (LAR) to give informed consent
5. Ability of children 14-17 years of age to provide assent
6. Ability to complete follow-up encounter at 30 days in person or by telephone

Exclusion Criteria:

1. Hospitalized recently (within last 28 days)
2. If they have been enrolled into this clinical trial previously
3. Surgery in the past 7 days
4. If they are unable or unwilling to complete the follow-up encounter
5. If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital)
6. If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials:

   1. Vasopressor therapy
   2. Cystic fibrosis
   3. Known severe immunosuppression (i. Cancer or another condition with neutropenia (absolute neutrophil count \<1000/ microL; ii. Solid- organ or hematopoietic stem-cell transplant within the previous 90 days; iii. Active graft-versus-host disease or bronchiolitis obliterans; iv. On chronic steroids equivalent to prednisone 20mg daily for ≥ 2 weeks or other targeted cytotoxic or biologic immunosuppressants within the prior 4 weeks; v. Human immunodeficiency virus infection with a CD4 cell count \<200/mm3)
   4. Have an accompanying non-respiratory infection
   5. Have evidence of a lung abscess or empyema
   6. Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation

Where this trial is running

Balapitiya and 2 other locations

• Base Hospital Balapitiya — Balapitiya, Sri Lanka (Recruiting)
• Galle National Hospital — Karapitiya, Sri Lanka (Recruiting)
• District General Hospital Matara — Matara, Sri Lanka (Recruiting)

Study contacts

• Principal investigator: Gayani Tillekeratne, MD, MSc — Duke University
• Study coordinator: Gayani Tillekeratne, MD, MSc

Conditions Lower Resp Tract Infection; eCDST