Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit

• ClinicalTrials.gov Identifier: NCT01878643
• Recruitment Status: Completed
• First Posted: June 17, 2013
• Last Update Posted: June 17, 2013
• Sponsor: Stony Brook University
• Information provided by (Responsible Party): Stony Brook University

Study Description

Brief Summary:

The purpose of this study was :

• to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients
• to determine the effect of inhaled antibiotics on respiratory infection

Condition or disease	Intervention/treatment	Phase
Respiratory Infection; Bacterial Resistance; Respiratory Failure	Drug: vancomycin or gentamicin; Drug: Placebo	Early Phase 1

Detailed Description:

Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance.

Systemic antibiotics are administered by the responsible physician

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
• Study Start Date: December 2001
• Actual Primary Completion Date: December 2002
• Actual Study Completion Date: December 2002

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Drug: Placebo; normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin	Drug: Placebo; normal saline administered to patient via nebulization; Other Name: Normal saline 2mL
Experimental: Drug: vancomycin or gentamicin; vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours	Drug: vancomycin or gentamicin; Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours; Other Names: gentamicin sulfate; vancomycin hydrocloride

Outcome Measures

Primary Outcome Measures :

1. Eradication of multi-drug resistant bacteria [ Time Frame: Randomization and at end of treatment ]

   Tracheal aspirates are taken at randomization. Randomization to drug is determined by the Gram stain(organisms are Gram-positive, Gram-negative or both). End of treatment culture, susceptibility and Gram stain of tracheal aspirate is taken after 14 days of treatment or at time of extubation, (which ever comes first).

   Eradication is defined as absence of growth in culture and absence of organisms on Gram stain.

Secondary Outcome Measures :

1. Clinical Pulmonary Infection Score (CPIS) [ Time Frame: Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first. ]
   CPIS is an index for risk of respiratory infection using a number of signs and symptoms . An index of greater than or equal to 6 suggests pneumonia

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• be on mechanical ventilation greater than 3 days
• greater than or equal to 18 years and survival greater than 14 days
• organisms on Gram stain with increasing purulent secretions

Exclusion Criteria:

• pregnancy
• allergy to drugs administered

Contacts and Locations

Locations

United States, New York

University Hospital Medical Center

STony Brook, New York, United States, 11794

Sponsors and Collaborators

Stony Brook University

Investigators

• Principal Investigator: Lucy B Palmer, MD; Stony Brook University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Palmer LB, Smaldone GC. Reduction of bacterial resistance with inhaled antibiotics in the intensive care unit. Am J Respir Crit Care Med. 2014 May 15;189(10):1225-33. doi: 10.1164/rccm.201312-2161OC.

• Responsible Party: Stony Brook University
• ClinicalTrials.gov Identifier: NCT01878643
• Other Study ID Numbers: 20033799
• First Posted: June 17, 2013
• Last Update Posted: June 17, 2013
• Last Verified: June 2013

Keywords provided by Stony Brook University:

aerosolized antibiotic; ventilator-associated pneumonia; bacterial resistance; ventilator -associated tracheobronchitis; clinical pulmonary infection score

Additional relevant MeSH terms:

Respiratory Tract Infections; Respiratory Insufficiency; Infection; Respiration Disorders; Respiratory Tract Diseases; Vancomycin; Gentamicins; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action