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Completed

NCT Number: NCT04438187

Trial of Antimicrobial Restraint in Presumed Pneumonia

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.

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Key information

Conditions

Healthcare-Associated Pneumonia Cross Infection Disease Attributes Iatrogenic Disease Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Medical Center

Kansas City, Kansas, 66160, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

antimicrobial initiation

Other

antimicrobial initiation based on protocol assignment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. In-hospital mortality

    Time frame: until hospital discharge or 1 year

    All-cause, by treatment protocol assignment (intent-to-treat), ICU mortality, pneumonia-related

  2. Days of antimicrobials administered

    Time frame: until hospital discharge or 1 year

    includes empiric, therapeutic, prophylactic, and perioperative antimicrobials

  3. Ventilator-free alive days

    Time frame: until hospital discharge or 1 year

  4. ICU length of stay

    Time frame: Until discharge from ICU or 1 year

  5. Hospital length of stay

    Time frame: until hospital discharge or 1 year

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Western Michigan University

Registry information

Acronym: TARPP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2020
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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