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

Lower Resp Tract Infection Clinical Trial

— TREAT-SL  

Official title:

TREATment of Lower Respiratory Tract Infection in 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 Southern Sri Lanka

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06331364
• Other study ID #: Pro00114347
• Secondary ID: R01AI168420
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Gayani Tillekeratne, MD, MSc
• Phone: (919) 681-7516
• Email: gayani.tillekeratne[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 765
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Lower Resp Tract Infection
• Respiratory Tract Infections

Intervention

Other:
• electronic clinical decision support tool (eCDST) diagnostic plan
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Allergy and Infectious Diseases (NIAID)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total duration of antibacterial prescription for the index visit	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).	Index hospitalization, up to approximately 30 days
Primary	Composite of adverse outcomes that could be attributed to withholding antibacterials	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.	Day 30
Secondary	Proportion of participants using non-invasive ventilation	Use of non-invasive ventilation (i.e., continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for treatment of the acute illness )	Day 30
Secondary	Proportion of participants using mechanical ventilation	Use of mechanical ventilation (via endotracheal tube)	Day 30
Secondary	Proportion of participants readmitted to the hospital	Proportion of participants readmitted to the hospital	Day 30
Secondary	Proportion of deaths	Proportion of deaths	Day 30
Secondary	Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription	Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription	Day 30
Secondary	Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization	Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization	Index hospitalization, up to approximately 30 days
Secondary	Duration of admission to the intensive care unit (ICU) during index hospitalization	Duration of admission to the intensive care unit (ICU) during index hospitalization	Index hospitalization, up to approximately 30 days
Secondary	Number of participants requiring use of supplemental oxygen by nasal cannula or face mask 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
Secondary	Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization	Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization	Index hospitalization, up to approximately 30 days
Secondary	Duration of non-invasive ventilation during index hospitalization	Duration of non-invasive ventilation during index hospitalization	Index hospitalization, up to approximately 30 days
Secondary	Duration of mechanical ventilation during index hospitalization	Duration of mechanical ventilation during index hospitalization	Index hospitalization, up to approximately 30 days
Secondary	Duration of index hospitalization	Duration of index hospitalization	Index hospitalization, up to approximately 30 days
Secondary	Proportion prescribed antibacterials- cumulative	Any prescription of antibacterials from enrollment to the point of assessment will be considered prescription of antibacterials.	Day 1, Day 2, Day 3, by discharge, and by Day 30
Secondary	Proportion prescribed antibacterials- at time of assessment	Prescription of antibacterials will only be assessed at the specific time of assessment	Day 1, Day 2, Day 3, by discharge, and by Day 30
Secondary	Total antibacterial exposure per patient during hospitalization	This is defined as the total number of days prescribed an antibacterial	Day 30
Secondary	Proportion prescribed oseltamivir- cumulative	Any prescription of oseltamivir from enrollment to the point of assessment will be considered prescription of oseltamivir	Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary	Proportion prescribed oseltamivir- at time of assessment	Prescription of oseltamivir will only be assessed at the specific time of assessment	Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary	Total oseltamivir exposure per patient during hospitalization	This is defined as the total number of days prescribed oseltamivir	Day 30
Secondary	Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative	Any prescription of SARS-CoV-2 antivirals from enrollment to the point of assessment will be considered prescription of SARS-CoV-2 antivirals	Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary	Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment	Prescription of SARS-CoV-2 antivirals will only be assessed at the specific time of assessment	Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary	Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed	Physician adherence to the eCDST diagnostic recommendations within 24 hours of receiving recommendations, in the intervention group.	24 hours
Secondary	Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed	Physician adherence to the eCDST diagnostic recommendations within 48 hours of receiving recommendations, in the intervention group.	48 hours
Secondary	Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed	Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed	24 hours and 48 hours
Secondary	Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed	Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed	24 hours and 48 hours
Secondary	Physician adherence, as measured by the proportion in whom all treatment recommendations were followed	Physician adherence, as measured by the proportion in whom all treatment recommendations were followed	24 hours and 48 hours