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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gayani.tillekeratne@duke.edu
• Phone: (919) 681-7760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.