TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL)

Not Applicable

Not yet recruiting

• Conditions: Lower Resp Tract Infection
• Interventions: Other: electronic clinical decision support tool (eCDST) diagnostic plan

• Registration Number: NCT06331364
• Lead Sponsor: Duke University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Start: 2025-09
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 765

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Arm	electronic clinical decision support tool (eCDST) diagnostic plan	Clinicians will be asked to use the diagnostic portion of the electronic clinical decision tool (eCDST) on their mobile phones, into which they will enter inputs and receive a diagnostic plan. Point of care (POC) testing as advised by the eCDST will be conducted by either clinical staff or trained research staff. If performed by research staff, results will be delivered on paper within 6 hours of testing to ≥ 2 primary clinicians on the team (including the consultant/ attending-level physician or senior registrar). THK, DGM, and DGH do not have an electronic medical record system. Clinicians will be asked to input the results from diagnostic testing and to follow the treatment recommendations as per the eCDST, but will be advised that the final decision regarding prescription of antimicrobials is entirely at their discretion.

Primary Outcome Measures

Name	Time	Method
Composite of adverse outcomes that could be attributed to withholding antibacterials	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.
Total duration of antibacterial prescription for the index visit	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 Outcome Measures

Name	Time	Method
Proportion of deaths	Day 30	Proportion of deaths
Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription	Day 30	Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription
Total antibacterial exposure per patient during hospitalization	Day 30	This is defined as the total number of days prescribed an antibacterial
Total oseltamivir exposure per patient during hospitalization	Day 30	This is defined as the total number of days prescribed oseltamivir
Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization	Index hospitalization, up to approximately 30 days	Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization
Duration of non-invasive ventilation during index hospitalization	Index hospitalization, up to approximately 30 days	Duration of non-invasive ventilation during index hospitalization
Duration of index hospitalization	Index hospitalization, up to approximately 30 days	Duration of index hospitalization
Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative	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
Physician adherence, as measured by the proportion in whom all treatment recommendations were followed	24 hours and 48 hours	Physician adherence, as measured by the proportion in whom all treatment recommendations were followed
Proportion of participants using non-invasive ventilation	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 )
Duration of admission to the intensive care unit (ICU) during index hospitalization	Index hospitalization, up to approximately 30 days	Duration of admission to the intensive care unit (ICU) during index hospitalization
Duration of mechanical ventilation during index hospitalization	Index hospitalization, up to approximately 30 days	Duration of mechanical ventilation during index hospitalization
Proportion prescribed oseltamivir- cumulative	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
Proportion of participants readmitted to the hospital	Day 30	Proportion of participants readmitted to the hospital
Proportion of participants using mechanical ventilation	Day 30	Use of mechanical ventilation (via endotracheal tube)
Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization	Index hospitalization, up to approximately 30 days	Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization
Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization	Index hospitalization, up to approximately 30 days	Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization
Proportion prescribed antibacterials- cumulative	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.
Proportion prescribed antibacterials- at time of assessment	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
Proportion prescribed oseltamivir- at time of assessment	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
Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed	24 hours and 48 hours	Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed
Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment	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
Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed	24 hours and 48 hours	Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed
Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed	24 hours	Physician adherence to the eCDST diagnostic recommendations within 24 hours of receiving recommendations, in the intervention group.
Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed	48 hours	Physician adherence to the eCDST diagnostic recommendations within 48 hours of receiving recommendations, in the intervention group.