Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

Ventilator Associated Pneumonia Clinical Trial

Official title:

Aerosolized Antibiotics in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396578
• Other study ID #: CORIHS # 2004-3799
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2006
• Last updated: November 6, 2006
• Start date: August 2003
• Est. completion date: September 2004

Study information

• Verified date: November 2006
• 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 aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

Description:

In patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. In this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. Neither the patients or their doctors knew what the patient was receiving.Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2004
• 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 of age survival greater than 14 days

• greater than 2 ccs of tracheal secretions/4 hours

Exclusion Criteria:

• allergy to drugs, pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Infection
• Respiratory Tract Infections
• Tracheobronchitis
• Ventilator Associated Pneumonia

Intervention

Drug:
• aerosolized vancomycin or gentamicin

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Nektar Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score
Secondary	Weaning from mechanical ventilation Bacterial resistance