NCT00396578

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
Last Updated

November 7, 2006

Status Verified

November 1, 2006

First QC Date

November 6, 2006

Last Update Submit

November 6, 2006

Conditions

Ventilator Associated PneumoniaRespiratory InfectionTracheobronchitis

Keywords

aerosolized antibioticsventilator associated pneumoniaclinical pulmonary infection scorebacterial resistance

Outcome Measures

Primary Outcomes (1)

  • Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary Outcomes (1)

  • Weaning from mechanical ventilation Bacterial resistance

Interventions

aerosolized vancomycin or gentamicinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • allergy to drugs, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Medical Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedRespiratory Tract Infections

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Lucy B Palmer, MD

    SUNY at Stony Brook

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 7, 2006

Study Start

August 1, 2003

Study Completion

September 1, 2004

Last Updated

November 7, 2006

Record last verified: 2006-11

Locations

US(1)