Trial of Antimicrobial Restraint in Presumed Pneumonia (TARPP)

November 15, 2022 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • KU Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Aggressive Arm
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.
Other: antimicrobial initiation
antimicrobial initiation based on protocol assignment.
OTHER: Conservative Arm
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.
Other: antimicrobial initiation
antimicrobial initiation based on protocol assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
protocol adherence
Time Frame: 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.
by time of culture finalization or 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: until hospital discharge or 1 year
All-cause, by treatment protocol assignment (intent-to-treat), ICU mortality, pneumonia-related
until hospital discharge or 1 year
Days of antimicrobials administered
Time Frame: until hospital discharge or 1 year
includes empiric, therapeutic, prophylactic, and perioperative antimicrobials
until hospital discharge or 1 year
Ventilator-free alive days
Time Frame: until hospital discharge or 1 year
until hospital discharge or 1 year
ICU length of stay
Time Frame: Until discharge from ICU or 1 year
Until discharge from ICU or 1 year
Hospital length of stay
Time Frame: until hospital discharge or 1 year
until hospital discharge or 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Western Michigan University

Investigators

  • Principal Investigator: Christopher Guidry, KU Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ACTUAL)

January 6, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (ACTUAL)

June 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 145059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

aggregated study results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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