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

Pneumonia, Bacterial Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554657
• Other study ID #: 201108280
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: March 14, 2012
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial

Intervention

Other:
• 5 Days of Antibiotics
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.
• 7 Days of Antibiotics therapy for pneumonia
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of antibiotic therapy		28 days	No
Secondary	Mortality		28 days	No
Secondary	Hospital Length of Stay		28 Days	No
Secondary	Clostridium difficile diarrhea		28 Days	No
Secondary	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.	28 days	No
Secondary	Recurrent lower respiratory tract infection		28 days	Yes