Clinical trial NCT06331364: TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL)
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Resp Tract Infection
Keywords: eCDST
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-03-26
Enrollment: 765
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge, cluster randomized, two-arm, open label

This design combines elements of a cluster randomized trial (intervention is applied in clusters) and a before-after design (each cluster switches to intervention). All 9 pairs of wards (clusters) will start with an initial period of usual care. At intervals of 3-6 months (steps), a set of 3 pairs of wards (clusters) will switch in a randomized order to use the intervention, until all pairs of wards have crossed over. We will use the stepped-wedge design since 1) this design may provide higher statistical power, since clusters act as their own controls, 2) to reduce contamination bias, and 3) to reduce the risk of a cluster dropping out of the study if assigned to the control group.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Composite of adverse outcomes that could be attributed to withholding antibacterials
timeFrame: Day 30
measure: Total duration of antibacterial prescription for the index visit
timeFrame: Index hospitalization, up to approximately 14 days
Secondary outcomes:
measure: Proportion of participants using non-invasive ventilation
timeFrame: Day 30
measure: Proportion of participants using mechanical ventilation
timeFrame: Day 30
measure: Proportion of participants readmitted to the hospital
timeFrame: Day 30
measure: Proportion of deaths
timeFrame: Day 30
measure: Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription
timeFrame: Day 30
measure: Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization
timeFrame: Index hospitalization, up to approximately 30 days
measure: Duration of admission to the intensive care unit (ICU) during index hospitalization
timeFrame: Index hospitalization, up to approximately 30 days
measure: Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization
timeFrame: Index hospitalization, up to approximately 30 days
measure: Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization
timeFrame: Index hospitalization, up to approximately 30 days
measure: Duration of non-invasive ventilation during index hospitalization
timeFrame: Index hospitalization, up to approximately 30 days
measure: Duration of mechanical ventilation during index hospitalization
timeFrame: Index hospitalization, up to approximately 30 days
measure: Duration of index hospitalization
timeFrame: Index hospitalization, up to approximately 30 days
measure: Proportion prescribed antibacterials- cumulative
timeFrame: Day 1, Day 2, Day 3, by discharge, and by Day 30
measure: Proportion prescribed antibacterials- at time of assessment
timeFrame: Day 1, Day 2, Day 3, by discharge, and by Day 30
measure: Total antibacterial exposure per patient during hospitalization
timeFrame: Day 30
measure: Proportion prescribed oseltamivir- cumulative
timeFrame: Day 1, Day 2, Day 3, at discharge, and by Day 30
measure: Proportion prescribed oseltamivir- at time of assessment
timeFrame: Day 1, Day 2, Day 3, at discharge, and by Day 30
measure: Total oseltamivir exposure per patient during hospitalization
timeFrame: Day 30
measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative
timeFrame: Day 1, Day 2, Day 3, at discharge, and by Day 30
measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment
timeFrame: Day 1, Day 2, Day 3, at discharge, and by Day 30
measure: Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed
timeFrame: 24 hours
measure: Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed
timeFrame: 48 hours
measure: Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed
timeFrame: 24 hours and 48 hours
measure: Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed
timeFrame: 24 hours and 48 hours
measure: Physician adherence, as measured by the proportion in whom all treatment recommendations were followed
timeFrame: 24 hours and 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Gayani Tillekeratne, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: