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

NCT01554657 | Completed DMC

• 1 other identifier: 201108280
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia, Bacterial

Keywords

Pneumonia, Bacterial

Outcome Measures

Primary Outcomes (1)

• Length of antibiotic therapy

  28 days

Secondary Outcomes (5)

• Mortality

  28 days

• Hospital Length of Stay

  28 Days

• Clostridium difficile diarrhea

  28 Days

• Development of a new multi-drug resistant bacteria from a lower respiratory tract culture

  28 days

• Recurrent lower respiratory tract infection

  28 days

Study Arms (2)

5 Days

EXPERIMENTAL

Other: 5 Days of Antibiotics

7 days

PLACEBO COMPARATOR

Other: 7 Days of Antibiotics therapy for pneumonia

Interventions

5 Days of Antibiotics 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.

5 Days

7 Days of Antibiotics therapy for pneumonia 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.

7 days

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

MeSH Terms

Conditions

Pneumonia, Bacterial

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

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

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 15, 2012
• Study Start: January 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 15, 2012

Record last verified: 2012-03