Viewing Study NCT00396578



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Study NCT ID: NCT00396578
Status: COMPLETED
Last Update Posted: 2006-11-07
First Post: 2006-11-06

Brief Title: Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation
Sponsor: Stony Brook University
Organization: Stony Brook University

Study Overview

Official Title: Aerosolized Antibiotics in Mechanically Ventilated Patients
Status: COMPLETED
Status Verified Date: 2006-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patientsWe 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
Detailed Description: In patients requiring mechanical ventilation signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patients 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 receivingNeed 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 systemicgiven in the vein antibiotic use and the development of organisms that were resistant to antibiotics

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None