Lower Respiratory Tract Infections
Conditions
Interventions
The study will be conducted at three public hospitals in Southern Province, Sri Lanka: Teaching Hospital Karapitiya (THK), District General Hospital Matara (DGM), and District General Hospital Hambant
Sponsors
Prof. Gayani Tillekeratne
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Admitted within prior 48 hours of admission to the hospital 2. Have evidence of new acute respiratory illness (20 breaths/minute) d. Abnormal lung examination 3. Have evidence of acute infection, as indicated by at least one of the following: a. Self-reported fever or chills b. Documented fever ?38 ?C (100.4 ?F) c. Documented hypothermia 10,000/mm3) e. Leukopenia (white blood cell count <3000/mm3) f. 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
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 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: a. Vasopressor therapy b. Cystic fibrosis c. 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); d. Have an accompanying non-respiratory infection e. Have evidence of a lung abscess or empyema 7,48 f. Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoint consisting of the following two endpoints: 1. Total duration of antibacterial prescription for the index visit (superiority analysis) 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). A day of antibacterial prescription will be defined as each day a subject is prescribed any oral, intramuscular, or intravenous antibacterial (may be non-consecutive days), excluding anti-virals, anti-fungals, or anti-parasitics. [30 days (after enrollment) or at discharge, whichever comes first] 2.Clinical outcomes by Day 30 (non-inferiority analysis) 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. At least one of the following adverse outcomes should be present to meet this endpoint: · Use of non-invasive ventilation (i.e., continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for treatment of the acute illness ) · Use of mechanical ventilation (via endotracheal tube) · Readmission to hospital ·Death [Day 1 will be day of enrollment, and participants will be followed through Day 30. [Assessed daily while hospitalized, and then at Day 30]] | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual components of the binary clinical outcome in the primary endpoint will be assessed [following are the individual components right?] 1. Diagnosis of lung abscess/ empyema 2. Diagnosis of pneumonia in non-pneumonia LRTI 3. Seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription (at Day 30) 4. Admission to and duration of admission to the intensive care unit (ICU) during index hospitalization 5. Use of and duration of use of supplemental oxygen by nasal cannula or high flow nasal cannula during index hospitalization 6. Duration of non-invasive ventilation during index hospitalization 7. Duration of mechanical ventilation during index hospitalization 8. Duration of index hospitalization 9. Prescription of antibacterials on Day 1, Day 2, Day 3, by discharge, and by Day 30. 10. Prescription of oseltamivir on Day 1, Day 2, Day 3, at discharge, and by Day 30. 11.Total oseltamivir exposure per patient (defined as the total number of days prescribed oseltamivir) during hospitalization and by Day 30. 12. Prescription of SARS-CoV-2 antivirals on Day 1, Day 2, Day 3, at discharge, and by Day 30. [Secondary outcomes 1-3 - At day 30 4-8 -At discharge or Day 30, whichever comes first 9-12 - At day 30] • Physician adherence to the eCDST diagnostic recommendations. [Within 24 hours and 48 hours of receiving recommendations, in the intervention group] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Warsha de Zoysa
Senior Lecturer, Department of Medicine, Faculty of Medicine, University of Ruhuna
Outcome results
None listed