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

NCT ID: NCT01554657

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

Pneumonia, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5 Days

Group Type: EXPERIMENTAL

5 Days of Antibiotics

Intervention Type: OTHER

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

Group Type: PLACEBO_COMPARATOR

7 Days of Antibiotics therapy for pneumonia

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

201108280

Identifier Type: -

Identifier Source: org_study_id