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

Stony Brook University

Status and phase: Completed; Early Phase 1

Conditions: Respiratory Failure; Bacterial Resistance; Respiratory Infection

Treatments: Drug: vancomycin or gentamicin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01878643

20033799

Details and patient eligibility

About

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 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

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

47 participants in 2 patient groups, including a placebo group

Drug: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: vancomycin or gentamicin

Experimental group

Description:

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

Treatment:

Drug: vancomycin or gentamicin