Healthcare-Associated Pneumonia, Sepsis
Conditions
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).
Interventions
OTHERantimicrobial initiation
antimicrobial initiation based on protocol assignment.
Sponsors
Western Michigan University
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a pragmatic, before-and-after, cluster-randomized, protocol crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| protocol adherence | by time of culture finalization or 1 week | as a pilot study the primary outcome will be protocol adherence as defined by using the criteria below: Aggressive Protocol: * Failure to send appropriate culture before initiation of antimicrobials in the absence of septic shock * Failure to stop antimicrobials in the absence of pneumonia or other documented infection after 72 hours. Conservative Protocol: * Failure to send appropriate culture * Initiation of antimicrobials (in the absence of septic shock, new onset or worsening organ dysfunction, or other indicated source of infection) without any objective evidence of pneumonia. * Failure to initiate antimicrobials in the setting of objective evidence of pneumonia. * Failure to stop antimicrobials in the absence of other documented infection if final cultures return as negative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | until hospital discharge or 1 year | All-cause, by treatment protocol assignment (intent-to-treat), ICU mortality, pneumonia-related |
| Days of antimicrobials administered | until hospital discharge or 1 year | includes empiric, therapeutic, prophylactic, and perioperative antimicrobials |
| Ventilator-free alive days | until hospital discharge or 1 year | — |
| ICU length of stay | Until discharge from ICU or 1 year | — |
| Hospital length of stay | until hospital discharge or 1 year | — |
Countries
United States
Outcome results
None listed