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Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

Aerosolized Antibiotics in Mechanically Ventilated Patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00396578
Enrollment
80
Registered
2006-11-07
Start date
2003-08-31
Completion date
2004-09-30
Last updated
2006-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infection, Tracheobronchitis, Ventilator Associated Pneumonia

Keywords

aerosolized antibiotics, ventilator associated pneumonia, clinical pulmonary infection score, bacterial resistance

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.

Detailed 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.

Interventions

DRUGaerosolized vancomycin or gentamicin

Sponsors

Nektar Therapeutics
CollaboratorINDUSTRY
Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary

MeasureTime frame
Weaning from mechanical ventilation Bacterial resistance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026