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Five Versus Seven Day Antibiotic Course for the Treatment of Pneumonia in the Intensive Care Unit

Primary Purpose

Pneumonia, Bacterial

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
5 Days of Antibiotics
7 Days of Antibiotics therapy for pneumonia
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Bacterial focused on measuring Pneumonia, Bacterial

Eligibility Criteria

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

Inclusion Criteria:

  • New diagnosis of pneumonia
  • Patient in medical or surgical intensive care unit
  • Age greater or equal than 18 years old

Exclusion Criteria:

  • Neutropenia
  • Recipient of a solid organ or bone marrow transplant
  • Bacteremia
  • Presence of Acinetobacter baumannii or Stenotrophomonas maltophilia from a respiratory tract culture
  • Presence of a second infection requiring antibiotic therapy
  • Pregnancy
  • Enrollment in another clinical study
  • Patient or surrogate unable to provide informed consent
  • Attending intensive care unit physician declined enrollment in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    5 Days

    7 days

    Arm Description

    Outcomes

    Primary Outcome Measures

    Length of antibiotic therapy

    Secondary Outcome Measures

    Mortality
    Hospital Length of Stay
    Clostridium difficile diarrhea
    Development of a new multi-drug resistant bacteria from a lower respiratory tract culture
    Patients will not receive routine follow-up respiratory cultures as part of the protocol. However, if a culture is obtained on a clinical basis and the culture grows a new multi-drug resistant bacteria, then this outcome is met. The outcome does NOT have a specific unit of measure as it is a measure of whether a multi-drug resistant bacteria is present or not. The definition for a multi-drug resistant bacteria is based on the definition provided by the European Centers for Disease Control.
    Recurrent lower respiratory tract infection

    Full Information

    First Posted
    March 7, 2012
    Last Updated
    March 14, 2012
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01554657
    Brief Title
    Five Versus Seven Day Antibiotic Course for the Treatment of Pneumonia in the Intensive Care Unit
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of the study is to determine if patients who are being treated for pneumonia in the intensive care unit can be safely treated with five days of antibiotics (the current standard is seven to eight days). The goal is to determine if the investigators can minimize antibiotic complications while still treating the infection. Patients in the study are randomly assigned to either receive antibiotics for a goal of five days or a goal of seven days. Every patient is followed daily, and if they are not responding to the antibiotics, the treating team in the intensive care unit care can continue the antibiotics for a longer course regardless of what group the patient is assigned. The investigator's hypothesis is that patients in the five day treatment goal will be able to receive less antibiotics than patients in the seven day treatment goal without any adverse effects.
    Detailed Description
    This is a pilot study to determine if patients with pneumonia in the intensive care unit can safely receive five days of antibiotics. All patients admitted to the medical and surgical intensive care units at Barnes-Jewish Hospital with pneumonia will be screened for the inclusion and exclusion criteria. Patients will be randomized by sealed envelopes in groups of six to a five or seven day course of antibiotics. The choice of the antibiotic to be used is determined by the intensive care unit treating team. The patients will NOT be randomized to a specific antibiotic. The patients will be followed for a clinical response by improvement in maximum daily temperature, white blood cell count, and PaO2 to FiO2 ratio. Antibiotics can continue past the goal duration for patients in either group if the above criteria are not met or if the attending physician in the intensive care unit feels that a longer course is needed. The treating team in the intensive care unit will not be blinded to the patient's treatment assignment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia, Bacterial
    Keywords
    Pneumonia, Bacterial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    5 Days
    Arm Type
    Experimental
    Arm Title
    7 days
    Arm Type
    Placebo Comparator
    Intervention Type
    Other
    Intervention Name(s)
    5 Days of Antibiotics
    Intervention Description
    The choice of the specific antibiotic is made by the treating intensive care unit attending physician. The patients will be randomized to two separate groups based on length of antibiotic therapy not specific antibiotics. Therefore, the actual antibiotic that will be given is not determined by the study. The patients all will receive antibiotics for pneumonia chosen by the intensive care unit team, and those in this group receive a goal of 5 days.
    Intervention Type
    Other
    Intervention Name(s)
    7 Days of Antibiotics therapy for pneumonia
    Intervention Description
    The choice of the specific antibiotic is made by the treating intensive care unit attending physician. The patients will be randomized to two separate groups based on length of antibiotic therapy not specific antibiotics. Therefore, the actual antibiotic that will be given is not determined by the study. The patients all will receive antibiotics for pneumonia that is determined by the treating intensive care unit team, and those in this group receive a goal of 7 days.
    Primary Outcome Measure Information:
    Title
    Length of antibiotic therapy
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    28 days
    Title
    Hospital Length of Stay
    Time Frame
    28 Days
    Title
    Clostridium difficile diarrhea
    Time Frame
    28 Days
    Title
    Development of a new multi-drug resistant bacteria from a lower respiratory tract culture
    Description
    Patients will not receive routine follow-up respiratory cultures as part of the protocol. However, if a culture is obtained on a clinical basis and the culture grows a new multi-drug resistant bacteria, then this outcome is met. The outcome does NOT have a specific unit of measure as it is a measure of whether a multi-drug resistant bacteria is present or not. The definition for a multi-drug resistant bacteria is based on the definition provided by the European Centers for Disease Control.
    Time Frame
    28 days
    Title
    Recurrent lower respiratory tract infection
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: New diagnosis of pneumonia Patient in medical or surgical intensive care unit Age greater or equal than 18 years old Exclusion Criteria: Neutropenia Recipient of a solid organ or bone marrow transplant Bacteremia Presence of Acinetobacter baumannii or Stenotrophomonas maltophilia from a respiratory tract culture Presence of a second infection requiring antibiotic therapy Pregnancy Enrollment in another clinical study Patient or surrogate unable to provide informed consent Attending intensive care unit physician declined enrollment in the study

    12. IPD Sharing Statement

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    Five Versus Seven Day Antibiotic Course for the Treatment of Pneumonia in the Intensive Care Unit

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