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Trial of Antimicrobial Restraint in Presumed Pneumonia (TARPP)

Primary Purpose

Healthcare-Associated Pneumonia, Sepsis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
antimicrobial initiation
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthcare-Associated Pneumonia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • KU Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Aggressive Arm

Conservative Arm

Arm Description

If an intubated patient is suspected of having an ICU-acquired HAP/VAP during the aggressive period, antimicrobials should be initiated immediately after quantitative or semi-quantitative endobronchial cultures are sent regardless of clinical status. This will include patients who, as determined by the attending intensivist, are in sepsis or septic shock. If, after 72 hours, cultures and other clinical data do not point to a pneumonia, the antimicrobials should be stopped in the absence of another source of infection.

If a patient is suspected of having an ICU-acquired HAP/VAP during the conservative period, quantitative or semi-quantitative endobronchial cultures should be sent. If the patient is in septic shock persistent hypotension requiring vasoactive medications to maintain mean arterial pressure (MAP) ≥65 mm HG or persistent lactic acidosis (>2 mmol/L) despite adequate resuscitation) antimicrobials will be initiated immediately. If the patient has new onset organ dysfunction that is presumed to be due to infection (sepsis) then antimicrobials will be initiated at the discretion of the attending intensivist. In the absence of septic shock or sepsis (intensivist discretion), antimicrobials will not be initiated unless objective evidence of pneumonia is present or another documented source of infection is identified mandating treatment with antimicrobials.

Outcomes

Primary Outcome Measures

protocol adherence
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 Outcome Measures

In-hospital mortality
All-cause, by treatment protocol assignment (intent-to-treat), ICU mortality, pneumonia-related
Days of antimicrobials administered
includes empiric, therapeutic, prophylactic, and perioperative antimicrobials
Ventilator-free alive days
ICU length of stay
Hospital length of stay

Full Information

First Posted
June 8, 2020
Last Updated
November 15, 2022
Sponsor
University of Kansas Medical Center
Collaborators
Western Michigan University
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1. Study Identification

Unique Protocol Identification Number
NCT04438187
Brief Title
Trial of Antimicrobial Restraint in Presumed Pneumonia
Acronym
TARPP
Official Title
Trial of Antimicrobial Restraint in Presumed Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Western Michigan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare-Associated Pneumonia, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This will be a pragmatic, before-and-after, cluster-randomized, protocol crossover study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aggressive Arm
Arm Type
Other
Arm Description
If an intubated patient is suspected of having an ICU-acquired HAP/VAP during the aggressive period, antimicrobials should be initiated immediately after quantitative or semi-quantitative endobronchial cultures are sent regardless of clinical status. This will include patients who, as determined by the attending intensivist, are in sepsis or septic shock. If, after 72 hours, cultures and other clinical data do not point to a pneumonia, the antimicrobials should be stopped in the absence of another source of infection.
Arm Title
Conservative Arm
Arm Type
Other
Arm Description
If a patient is suspected of having an ICU-acquired HAP/VAP during the conservative period, quantitative or semi-quantitative endobronchial cultures should be sent. If the patient is in septic shock persistent hypotension requiring vasoactive medications to maintain mean arterial pressure (MAP) ≥65 mm HG or persistent lactic acidosis (>2 mmol/L) despite adequate resuscitation) antimicrobials will be initiated immediately. If the patient has new onset organ dysfunction that is presumed to be due to infection (sepsis) then antimicrobials will be initiated at the discretion of the attending intensivist. In the absence of septic shock or sepsis (intensivist discretion), antimicrobials will not be initiated unless objective evidence of pneumonia is present or another documented source of infection is identified mandating treatment with antimicrobials.
Intervention Type
Other
Intervention Name(s)
antimicrobial initiation
Intervention Description
antimicrobial initiation based on protocol assignment.
Primary Outcome Measure Information:
Title
protocol adherence
Description
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.
Time Frame
by time of culture finalization or 1 week
Secondary Outcome Measure Information:
Title
In-hospital mortality
Description
All-cause, by treatment protocol assignment (intent-to-treat), ICU mortality, pneumonia-related
Time Frame
until hospital discharge or 1 year
Title
Days of antimicrobials administered
Description
includes empiric, therapeutic, prophylactic, and perioperative antimicrobials
Time Frame
until hospital discharge or 1 year
Title
Ventilator-free alive days
Time Frame
until hospital discharge or 1 year
Title
ICU length of stay
Time Frame
Until discharge from ICU or 1 year
Title
Hospital length of stay
Time Frame
until hospital discharge or 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Guidry
Organizational Affiliation
KU Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
aggregated study results
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Trial of Antimicrobial Restraint in Presumed Pneumonia

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