Ventilator Associated PneumoniaPhase 2NCT00396578
Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation
A Phase 2 study testing aerosolized vancomycin or gentamicin in people with Ventilator Associated Pneumonia and Respiratory Infection, run by Stony Brook University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Respiratory Infection, Tracheobronchitis
- What is being tested?
- aerosolized vancomycin or gentamicin
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- allergy to drugs, pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital Medical Center
Stony Brook, New York, 11794
About this study
Official title: Aerosolized Antibiotics in Mechanically Ventilated Patients
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.
Read the 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.
- Being tested
- aerosolized vancomycin or gentamicin
- Keywords
- aerosolized antibiotics, ventilator associated pneumonia, clinical pulmonary infection score, bacterial resistance
- Medical subject headings
- Pneumonia, Ventilator-Associated, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosolized vancomycin or gentamicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score
Secondary outcomes (1)
Weaning from mechanical ventilation Bacterial resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startAug 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Nektar Therapeutics
- Investigators
- Lucy B Palmer, MD, Principal investigator, SUNY at Stony Brook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396578
- Sponsor's protocol ID
- CORIHS # 2004-3799
- Status last verified
- Nov 2006
- First submitted
- 6 Nov 2006
- Last updated
- 7 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosolized Antibiotics in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT00396578
- Acronym / sponsor ID
- CORIHS # 2004-3799
- Keywords
- aerosolized antibiotics, ventilator associated pneumonia, clinical pulmonary infection score, bacterial resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Nektar Therapeutics
- Study start
- Aug 2003
- Study completion
- Sep 2004
- First posted
- 7 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- allergy to drugs, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerosolized vancomycin or gentamicin | Drug | – |
Primary outcome
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score
1 secondary outcome
Weaning from mechanical ventilation Bacterial resistance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy B Palmer, MD principal investigator
SUNY at Stony Brook
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aerosolized vancomycin or gentamicin in people with Ventilator Associated Pneumonia and Respiratory Infection, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2006.