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Completed

NCT Number: NCT01554657

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Length of antibiotic therapy

    Time frame: 28 days

Secondary outcomes

  1. Mortality

    Time frame: 28 days

  2. Hospital Length of Stay

    Time frame: 28 Days

  3. Clostridium difficile diarrhea

    Time frame: 28 Days

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

    Time frame: 28 days

    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.

  5. Recurrent lower respiratory tract infection

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2012
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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