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
About this trial
This is an interventional treatment trial for Pneumonia, Bacterial focused on measuring Pneumonia, Bacterial
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
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
NCT ID
NCT01554657
First Posted
March 7, 2012
Last Updated
March 14, 2012
Sponsor
Washington University School of Medicine
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
Learn more about this trial
Five Versus Seven Day Antibiotic Course for the Treatment of Pneumonia in the Intensive Care Unit
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