Respiratory InfectionEarly Phase 1NCT01878643
Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
A Early Phase 1 study testing vancomycin or gentamicin in people with Respiratory Infection and Bacterial Resistance, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study was : to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients to determine the effect of inhaled antibiotics on respiratory infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Infection, Bacterial Resistance, Respiratory Failure
- What is being tested?
- vancomycin or gentamicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Dec 2002
- Phase
- Early Phase 1
- 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 and survival greater than 14 days
- organisms on Gram stain with increasing purulent secretions
Who cannot join
- pregnancy
- allergy to drugs administered
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: Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
The purpose of this study was :
- to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients
- to determine the effect of inhaled antibiotics on respiratory infection
Read the detailed description
Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance.
Systemic antibiotics are administered by the responsible physician
- Being tested
- vancomycin or gentamicin, Placebo
- Keywords
- aerosolized antibiotic, ventilator-associated pneumonia, bacterial resistance, ventilator -associated tracheobronchitis, clinical pulmonary infection score
- Medical subject headings
- Respiratory Tract Infections, Respiratory Insufficiency, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin or gentamicinDrug
Also called gentamicin sulfate, vancomycin hydrocloride
Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours
PlaceboDrug
Also called Normal saline 2mL
normal saline administered to patient via nebulization
| Study group | Role | What they receive |
|---|---|---|
| Drug: Placebo | Placebo comparator | normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin Receives: Drug: Placebo |
| Drug: vancomycin or gentamicin | Experimental | vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours Receives: Drug: vancomycin or gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of multi-drug resistant bacteria
Tracheal aspirates are taken at randomization. Randomization to drug is determined by the Gram stain(organisms are Gram-positive, Gram-negative or both). End of treatment culture, susceptibility and Gram stain of tracheal aspirate is taken after 14 days of treatment or at time of extubation, (which ever comes first).
Eradication is defined as absence of growth in culture and absence of organisms on Gram stain.
Measured: Randomization and at end of treatment
Secondary outcomes (1)
Clinical Pulmonary Infection Score (CPIS)
CPIS is an index for risk of respiratory infection using a number of signs and symptoms . An index of greater than or equal to 6 suggests pneumonia
Measured: Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startDec 2001
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy B Palmer, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878643
- Sponsor's protocol ID
- 20033799
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmer LB, Smaldone GC. Reduction of bacterial resistance with inhaled antibiotics in the intensive care unit. Am J Respir Crit Care Med. 2014 May 15;189(10):1225-33. doi: 10.1164/rccm.201312-2161OC.
PubMed 24646034
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
- ClinicalTrials.gov ID
- NCT01878643
- Acronym / sponsor ID
- 20033799
- Keywords
- aerosolized antibiotic, ventilator-associated pneumonia, bacterial resistance, ventilator -associated tracheobronchitis, clinical pulmonary infection score
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 17 Jun 2013 (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 inhaled antibiotics on airway bacteria in ventilated patients
- to determine the effect of inhaled antibiotics on respiratory infection
Detailed description
Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance.
Systemic antibiotics are administered by the responsible physician
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Placebo | Placebo comparator | Drug: Placebonormal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin |
| Drug: vancomycin or gentamicin | Experimental | Drug: vancomycin or gentamicinvancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours |
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 and survival greater than 14 days
- organisms on Gram stain with increasing purulent secretions
Key exclusion criteria (2 listed)
- pregnancy
- allergy to drugs administered
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 |
|---|---|---|
| vancomycin or gentamicinAlso: gentamicin sulfate, vancomycin hydroclorideChoice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours | Drug | Drug: vancomycin or gentamicin |
| PlaceboAlso: Normal saline 2mLnormal saline administered to patient via nebulization | Drug | Drug: Placebo |
Primary outcome
Eradication of multi-drug resistant bacteria
Time frame: Randomization and at end of treatment
Tracheal aspirates are taken at randomization. Randomization to drug is determined by the Gram stain(organisms are Gram-positive, Gram-negative or both). End of treatment culture, susceptibility and Gram stain of tracheal aspirate is taken after 14 days of treatment or at time of extubation, (which ever comes first). Eradication is defined as absence of growth in culture and absence of organisms on Gram stain.
1 secondary outcome
Clinical Pulmonary Infection Score (CPIS)
Time frame: Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.
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 17 Jun 2013.
- Derived from this study: PubMed 24646034Palmer LB, Smaldone GC. Reduction of bacterial resistance with inhaled antibiotics in the intensive care unit. Am J Respir Crit Care Med. 2014 May 15;189(10):1225-33. doi: 10.1164/rccm.201312-2161OC.
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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
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing vancomycin or gentamicin in people with Respiratory Infection and Bacterial Resistance, 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 2 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 17 Jun 2013. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Eradication of multi-drug resistant bacteria (time frame: Randomization and at end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878643, which also lists 1 linked publication.
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 17 Jun 2013.