Trial of Antimicrobial Restraint in Presumed Pneumonia

NCT04438187 | Completed DMC

• 1 other identifier: 145059
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthcare-Associated Pneumonia; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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.

  by time of culture finalization or 1 week

Secondary Outcomes (5)

• In-hospital mortality

  until hospital discharge or 1 year

• Days of antimicrobials administered

  until hospital discharge or 1 year

• 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

Study Arms (2)

Aggressive Arm

OTHER

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

Conservative Arm

OTHER

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

Interventions

antimicrobial initiation OTHER

antimicrobial initiation based on protocol assignment.

Aggressive Arm; Conservative Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Western Michigan University: collaborator

Study Sites (1)

KU Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (30)

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  PMID: 36534474 DERIVED

Related Links

• Trial of antibiotic restraint in presumed pneumonia: A Surgical Infection Society multicenter pilot

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Guidry

  KU Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a pragmatic, before-and-after, cluster-randomized, protocol crossover study.

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 18, 2020
• Study Start: February 1, 2021
• Primary Completion: January 6, 2022
• Study Completion: June 30, 2022
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)