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

NCT01878643 | Completed Early Phase 1

• 1 other identifier: 20033799
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Infection; Bacterial Resistance; Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Eradication of multi-drug resistant bacteria

  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.

  Randomization and at end of treatment

Secondary Outcomes (1)

• Clinical Pulmonary Infection Score (CPIS)

  Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.

Study Arms (2)

Drug: Placebo

PLACEBO COMPARATOR

normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin

Drug: Placebo

Drug: vancomycin or gentamicin

EXPERIMENTAL

vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours

Drug: vancomycin or gentamicin

Interventions

vancomycin or gentamicin DRUG

Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours

Also known as: gentamicin sulfate, vancomycin hydrocloride

Drug: vancomycin or gentamicin

Placebo DRUG

normal saline administered to patient via nebulization

Also known as: Normal saline 2mL

Drug: Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• allergy to drugs administered

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

University Hospital Medical Center

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

• 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.

  PMID: 24646034 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Respiratory Insufficiency; Pneumonia, Ventilator-Associated

Interventions

Vancomycin; Gentamicins; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Respiration Disorders; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Aminoglycosides; Glycosides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lucy B Palmer, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 17, 2013
• Study Start: December 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

US (1)