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

Respiratory Failure Clinical Trial

Official title:

Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878643
• Other study ID #: 20033799
• Status: Completed
• Phase: Phase 0
• First received: June 7, 2013
• Last updated: June 12, 2013
• Start date: December 2001
• Est. completion date: December 2002

Study information

• Verified date: June 2013
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Resistance
• Respiratory Failure
• Respiratory Infection
• Respiratory Insufficiency
• Respiratory Tract Infections

Intervention

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
• Placebo
normal saline administered to patient via nebulization

Locations

Country	Name	City	State
United States	University Hospital Medical Center	STony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Clinical Pulmonary Infection Score (CPIS)	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	Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.	No