Clinical trial NCT04438187: Trial of Antimicrobial Restraint in Presumed Pneumonia
Official title: Trial of Antimicrobial Restraint in Presumed Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare-Associated Pneumonia
Sepsis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Western Michigan University
First posted: 2020-06-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a pragmatic, before-and-after, cluster-randomized, protocol crossover study.
Primary purpose: TREATMENT

Brief summary: The objective of this cluster-randomized crossover study is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock.

Detailed description: This study will involve 8 centers is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock. The study team will compare two sequential 4-month periods in each unit, one 'aggressive' antimicrobial initiation period and one 'conservative' antimicrobial initiation period.

This study will serve the following specific aims:

Specific Aim 1: To determine feasibility of a larger multicenter study of the same design as well as assess protocol adherence across multiple centers.

Specific Aim 2: Prospectively determine the all-cause, in-hospital mortality for all patients with suspected pneumonia who were treated under either an aggressive or conservative antimicrobial initiation protocol.

Specific Aim 3: Prospectively determine antimicrobial initiation rates, total days of antimicrobial administration, hospital and ICU length of stay, and ventilator-free alive days for patients treated under each protocol.

Specific Aim 4: To survey physicians that participated in the study to assess their feelings about the study including level of comfort starting antimicrobials aggressively, level of comfort withholding antimicrobials until definitive evidence of infection, perceived protocol adherence, perceived importance of the study, and willingness to participate in other studies of its kind (to be performed after closure of the clinical portion of the study).

Eligibility criteria: Inclusion Criteria:

* Intubated patients admitted to a surgical or trauma intensive care unit that have had an appropriate quantitative or semi-quantitative endobronchial sputum culture sent ≥48 hours into their ICU admission
* Primary pathology managed by surgical specialty
* Age ≥18 years.

Exclusion Criteria:

* Non-intubated patients.
* Intubated patients with concern for active infection that is not suspected to be pneumonia (i.e. intra-abdominal infection, skin and soft tissue infection, urinary tract infection, etc.)
* Primary disease not surgical or traumatic in nature
* Primary diagnosis of burns
* Incarcerated status
* Pregnant status or delivery during this hospitalization.
* On active immunosuppressive medications (or taking as a home medication prior to arrival)

Primary outcomes:
measure: protocol adherence
timeFrame: by time of culture finalization or 1 week
Secondary outcomes:
measure: In-hospital mortality
timeFrame: until hospital discharge or 1 year
measure: Days of antimicrobials administered
timeFrame: until hospital discharge or 1 year
measure: Ventilator-free alive days
timeFrame: until hospital discharge or 1 year
measure: ICU length of stay
timeFrame: Until discharge from ICU or 1 year
measure: Hospital length of stay
timeFrame: until hospital discharge or 1 year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: KU Medical Center
state: Kansas
Study officials:
affiliation: KU Medical Center
name: Christopher Guidry
role: PRINCIPAL_INVESTIGATOR
References:
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