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NCT Number: NCT06331364

TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial

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).

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Key information

Conditions

Lower Resp Tract Infection

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Base Hospital Balapitiya, Balapitiya, Sri Lanka

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Hospitalized recently (within last 28 days)
  • If they have been enrolled into this clinical trial previously
  • Surgery in the past 7 days
  • If they are unable or unwilling to complete the follow-up encounter
  • If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital)
  • If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials:
  • Vasopressor therapy
  • Cystic fibrosis
  • 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)
  • Have an accompanying non-respiratory infection
  • Have evidence of a lung abscess or empyema
  • Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation

Treatment and study plan

electronic clinical decision support tool (eCDST) diagnostic plan

Other

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.

Primary outcomes

  1. Composite of adverse outcomes that could be attributed to withholding antibacterials

    Time frame: Day 30

    A binary clinical endpoint consisting of a composite of adverse outcomes that could be attributed to withholding antibacterials. These outcomes would not be present at enrollment, and could occur anytime until Day 30.

  2. Total duration of antibacterial prescription for the index visit

    Time frame: Index hospitalization, up to approximately 14 days

    Total duration of antibacterial prescription for the index visit will include the number of days that antibacterials are prescribed during the index hospitalization, as well as the number of days that antibacterials are prescribed at discharge from the hospital (intended use).

Secondary outcomes

  1. Proportion of participants using non-invasive ventilation

    Time frame: Day 30

    Use of non-invasive ventilation (i.e., continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for treatment of the acute illness )

  2. Proportion of participants using mechanical ventilation

    Time frame: Day 30

    Use of mechanical ventilation (via endotracheal tube)

  3. Proportion of participants readmitted to the hospital

    Time frame: Day 30

    Proportion of participants readmitted to the hospital

  4. Proportion of deaths

    Time frame: Day 30

    Proportion of deaths

  5. Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription

    Time frame: Day 30

    Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription

  6. Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization

    Time frame: Index hospitalization, up to approximately 30 days

    Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization

  7. Duration of admission to the intensive care unit (ICU) during index hospitalization

    Time frame: Index hospitalization, up to approximately 30 days

    Duration of admission to the intensive care unit (ICU) during index hospitalization

  8. Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization

    Time frame: Index hospitalization, up to approximately 30 days

    Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization

  9. Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization

    Time frame: Index hospitalization, up to approximately 30 days

    Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization

  10. Duration of non-invasive ventilation during index hospitalization

    Time frame: Index hospitalization, up to approximately 30 days

    Duration of non-invasive ventilation during index hospitalization

  11. Duration of mechanical ventilation during index hospitalization

    Time frame: Index hospitalization, up to approximately 30 days

    Duration of mechanical ventilation during index hospitalization

  12. Duration of index hospitalization

    Time frame: Index hospitalization, up to approximately 30 days

    Duration of index hospitalization

  13. Proportion prescribed antibacterials- cumulative

    Time frame: Day 1, Day 2, Day 3, by discharge, and by Day 30

    Any prescription of antibacterials from enrollment to the point of assessment will be considered prescription of antibacterials.

  14. Proportion prescribed antibacterials- at time of assessment

    Time frame: Day 1, Day 2, Day 3, by discharge, and by Day 30

    Prescription of antibacterials will only be assessed at the specific time of assessment

  15. Total antibacterial exposure per patient during hospitalization

    Time frame: Day 30

    This is defined as the total number of days prescribed an antibacterial

  16. Proportion prescribed oseltamivir- cumulative

    Time frame: Day 1, Day 2, Day 3, at discharge, and by Day 30

    Any prescription of oseltamivir from enrollment to the point of assessment will be considered prescription of oseltamivir

  17. Proportion prescribed oseltamivir- at time of assessment

    Time frame: Day 1, Day 2, Day 3, at discharge, and by Day 30

    Prescription of oseltamivir will only be assessed at the specific time of assessment

  18. Total oseltamivir exposure per patient during hospitalization

    Time frame: Day 30

    This is defined as the total number of days prescribed oseltamivir

  19. Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative

    Time frame: Day 1, Day 2, Day 3, at discharge, and by Day 30

    Any prescription of SARS-CoV-2 antivirals from enrollment to the point of assessment will be considered prescription of SARS-CoV-2 antivirals

  20. Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment

    Time frame: Day 1, Day 2, Day 3, at discharge, and by Day 30

    Prescription of SARS-CoV-2 antivirals will only be assessed at the specific time of assessment

  21. Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed

    Time frame: 24 hours

    Physician adherence to the eCDST diagnostic recommendations within 24 hours of receiving recommendations, in the intervention group.

  22. Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed

    Time frame: 48 hours

    Physician adherence to the eCDST diagnostic recommendations within 48 hours of receiving recommendations, in the intervention group.

  23. Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed

    Time frame: 24 hours and 48 hours

    Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed

  24. Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed

    Time frame: 24 hours and 48 hours

    Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed

  25. Physician adherence, as measured by the proportion in whom all treatment recommendations were followed

    Time frame: 24 hours and 48 hours

    Physician adherence, as measured by the proportion in whom all treatment recommendations were followed

Study contacts

Contact information is provided by the study sponsor or research team.

Gayani Tillekeratne, MD, MSc

CONTACT

[email protected]

(919) 681-7760

Stefany Olague, MPH

CONTACT

[email protected]

(919)668-8131

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Acronym: TREAT-SL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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