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

Overview

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

Full Title of Study: “Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2002

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

Interventions

  • 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
  • Drug: Placebo
    • normal saline administered to patient via nebulization

Arms, Groups and Cohorts

  • Placebo Comparator: Drug: Placebo
    • normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
  • Experimental: Drug: vancomycin or gentamicin
    • vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stony Brook University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lucy B Palmer, MD, Principal Investigator, Stony Brook University

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