Infectious diseases Infections and Infestations Infectious diseases
Conditions
Interventions
Current interventions as of 12/02/2020:
Participants are randomly allocated to either the intervention or the control group using a 1:1 software randomization service.
Intervention group: Participant
Sponsors
Southampton General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 12/02/2020: 1. Admitted to the Respiratory High Dependency Unit (RHDU), or an Intensive Care Unit (ICU), or about to be transferred to RHDU, GICU, NICU or under the care of the RHDU or ICU team in another hospital area, within University Hospital Southampton NHS Foundation Trust (UHS) 2. Aged =18 years 3. Has a working diagnosis of CAP, HAP or VAP* and physician decides to start new antibiotic treatment or modify existing antibiotic treatment. *CAP defined by the BTS as: ‘symptoms and signs of acute lower respiratory tract infection associated with new radiographic shadowing for which there is no other explanation’. CAP patients who are intubated and ventilated remain classified as CAP. HAP defined as by the IDSA as: ‘new lung infiltrate, plus clinical evidence that the infiltrate is of an infectious origin, which includes the new onset of fever, purulent sputum, leucocytosis, and decline in oxygenation... arising >48 h after hospital admission’. HAP patients who are intubated and ventilated remain classified as HAP. VAP defined as by the IDSA as: ‘new lung infiltrate plus clinical evidence that the infiltrate is of an infectious origin, which include the new onset of fever, purulent sputum, leucocytosis, and decline in oxygenation... occurring >48 h after endotracheal intubation’ Previous participant inclusion criteria: 1. Admitted to the Respiratory High Dependency Unit (RHDU), or an Intensive Care Unit (ICU), or about to be transferred to either RHDU or ICU, or under the care of the RHDU or ICU team in another hospital area, within University Hospital Southampton NHS Foundation Trust (UHS) 2. Aged =18 years old 3. Duration of respiratory illness less than 10 days prior to hospitalisation 4. Presented to hospital less than 72 hours prior to enrolment 5. Has a severe acute respiratory illness* *An episode of severe acute respiratory illness is defined as an acute pulmonary illness (including pneumonia, bronchitis and influenza-like illness) or an acute exacerbation of a chronic respiratory illness (including exacerbation of COPD, asthma or bronchiectasis), requiring high dependency or intensive care. For the study, a severe acute respiratory illness as a provisional, working, differential or confirmed diagnosis must be made by a treating clinician.
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 12/02/2020: 1. A purely palliative approach being taken by the treating clinicians 2. Previously included in this study 3. Consent declined or consultee consent declined 4. Underlying Cystic Fibrosis or other condition characterized by persistent colonization with resistant organisms 5. Not expected to survive the next 24 h in the opinion of the responsible clinical team Involvement in observational trials may not exclude a participant from this trial, and this is at the CI’s discretion. Previous participant exclusion criteria: 1. Not fulfilling all the inclusion criteria 2. A purely palliative approach being taken by the treating clinicians 3. Previously included in this study 4. Declines nasal / pharyngeal swabbing 5. Consent declined or consultee consent declined 6. Severe acute respiratory illness is related to solely to critical illness and/or is not the principal illness leading to ICU/HDU admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/03/2021: The proportion of patients treated with results directed antimicrobials within 48 hours of a lower respiratory tract test result (this is defined as the use of antimicrobial agents that are started or continued on the basis of appropriateness (or the optimal choice) for a detected pathogen(s), where a putative pathogen(s) considered by the investigators to be plausibly causative, is identified; or the appropriate de-escalation or cessation of antimicrobials occurs where no pathogen is identified). Previous primary outcome measure from 12/02/2020 to 19/03/2021: All primary and secondary outcome measures are measured retrospectively using electronic hospital case notes at the end of hospital stay or 30 days, and 60 days. The proportion of patients treated with results directed antimicrobials. This is defined as the use of antimicrobial agents that are started or continued on the basis of appropriateness (or the optimal choice) for a detected pathogen(s), where a putative pathogen(s) considered by the investigators to be plausibly causative, is identified; or the appropriate de-escalation or cessation of antimicrobials occurs where no pathogen is identified. Original primary outcome measure: Proportion of influenza-positive patients treated with neuraminidase inhibitors (NAI) within 7 days of admission to hospital, measured retrospectively on discharge or at 30 days, using electronic hospital prescribing systems | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/03/2021: 1. Median time to results directed antimicrobial therapy within 48 hours of a lower respiratory tract test result, days 2. Proportion with results-directed escalation or de-escalation in antimicrobial therapy within 48 hours of a lower respiratory tract test result. Escalation/de-escalation defined as addition/ cessation of a second agent or increase/decrease in antibiotic stewardship ‘ranking’ 3. Median time to results directed escalation/ de-escalation within 48 hours of lower respiratory tract result, hours 4. Proportion treated with ineffective empirical antimicrobial therapy (defined by the absence of an antimicrobial agent active against the specific class of microorganisms responsible for the infection or the administration of an antimicrobial agent to which the microorganism responsible for infection is resistant) at recruitment 5. Median duration of ineffective antimicrobial therapy (hours), up to 14 days 6. Median duration of all antimicrobial therapy for this episode of pneumonia (hours), up to 14 days 7. Median number of different antimicrobial agents used for this episode of pneumonia (hours) up to 14 days 8. Number of antibiotic-free hours in the 14 days following recruitment 9. Median number of hours piperacillin/tazobactam in the 14 days following recruitment 10. Median number of hours of meropenem in the 14 days following recruitment 11. Median turn-around time for results, hours and days 12. Proportion of patients with a credible pathogen identified for this episode of pneumonia. Credible pathogen as determined by two independent infection specialists, with a third adjudicating in event of disagreement. 13. Concordance between pathogen identification between molecular methods (FilmArray) and culture 14. Concordance between genotypic and phenotypic isolate sensitivities 15. Proportionate in-hospital, 30- and 60-day mortality 16. Median duration of hospitalisation (days), measured for the duratio | — |
Countries
England, United Kingdom
Contacts
Public ContactTristan;Stephen Clark;Poole
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Outcome results
None listed