Pneumonia, StaphylococcalPhase 2NCT01925066
Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
A Phase 2 study testing Vancomycin in people with Pneumonia, Staphylococcal and Methicillin-Resistant Staphylococcus Aureus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether aerosolized vancomycin is effective in the treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical ventilation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pneumonia, Staphylococcal, Methicillin-Resistant Staphylococcus Aureus
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Dec 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nosocomial or severe community-acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus
- Must be mechanically ventilated in intensive care unit
Who cannot join
- Non-bacterial pneumonia, such as viral, fungal, tuberculosis infections
- Underlying respiratory condition: bronchiectasis, post-tuberculosis, chronic obstructive pulmonary disease or asthma
- Complicated pneumonia, such as empyema, parapneumonic effusion requiring chest tube or drainage
- Already or previous treated with intravenous vancomycin (Not pneumonia)
- Adverse reaction due to inhaled ventolin before treatment of aerosolized vancomycin
- Hypersensitivity of vancomycin or glycopeptide antibiotics
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- Positive culture of Enterococcus in respiratory specimen
- Pregnant or Breast-feeding patient
- Immunocompromised hosts: more than 1mg/kg of corticosteroid users for more than 3 months, transplantation recipients, AIDS patients
- Another aerosolized antibiotics within 48 hours of study enrollment
- Not adherent to mechanical ventilation protocol of this study
- Not arterial line monitoring
- Vancomycin minimum inhibitory concentration >= 2㎍/㎖ of cultured Staphylococcus aureus
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Optimal Two-Stage Phase 2 Study of Efficacy and Pharmacokinetics of Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
The purpose of this study is to determine whether aerosolized vancomycin is effective in the treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical ventilation.
- Being tested
- Vancomycin
- Medical subject headings
- Pneumonia, Staphylococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called 250mg bid, Inhalation for 5-7 days
| Study group | Role | What they receive |
|---|---|---|
| Aerosolized Vancomycin | Experimental | Not described Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical cure rate
Measured: within the first 30 days after treatment
Secondary outcomes (1)
the peak level of serum vancomycin level
Measured: on 3rd and 5th days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, StaphylococcalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Sponsor
- Investigators
- Jae-Joon Yim, MD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925066
- Sponsor's protocol ID
- B-1206-156-004
- Status last verified
- Apr 2019
- First submitted
- 15 Aug 2013
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
PubMed 2702835Cho JY, Kim HS, Yang HJ, Lee YJ, Park JS, Yoon HI, Kim HB, Yim JJ, Lee JH, Lee CT, Cho YJ. Pilot Study of Aerosolised Plus Intravenous Vancomycin in Mechanically Ventilated Patients with Methicillin-Resistant Staphylococcus Aureus Pneumonia. J Clin Med. 2020 Feb 9;9(2):476. doi: 10.3390/jcm9020476.
PubMed 32050447
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Two-Stage Phase 2 Study of Efficacy and Pharmacokinetics of Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01925066
- Acronym / sponsor ID
- B-1206-156-004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Aug 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Aug 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 is to determine whether aerosolized vancomycin is effective in the treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerosolized Vancomycin | Experimental | Drug: Vancomycin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nosocomial or severe community-acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus
- Must be mechanically ventilated in intensive care unit
Key exclusion criteria (13 listed)
- Non-bacterial pneumonia, such as viral, fungal, tuberculosis infections
- Underlying respiratory condition: bronchiectasis, post-tuberculosis, chronic obstructive pulmonary disease or asthma
- Complicated pneumonia, such as empyema, parapneumonic effusion requiring chest tube or drainage
- Already or previous treated with intravenous vancomycin (Not pneumonia)
- Adverse reaction due to inhaled ventolin before treatment of aerosolized vancomycin
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 |
|---|---|---|
| VancomycinAlso: 250mg bid, Inhalation for 5-7 days | Drug | Aerosolized Vancomycin |
Primary outcome
clinical cure rate
Time frame: within the first 30 days after treatment
1 secondary outcome
the peak level of serum vancomycin level
Time frame: on 3rd and 5th days after treatment
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 23 Apr 2019.
- Background: PubMed 2702835Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
- Derived from this study: PubMed 32050447Cho JY, Kim HS, Yang HJ, Lee YJ, Park JS, Yoon HI, Kim HB, Yim JJ, Lee JH, Lee CT, Cho YJ. Pilot Study of Aerosolised Plus Intravenous Vancomycin in Mechanically Ventilated Patients with Methicillin-Resistant Staphylococcus Aureus Pneumonia. J Clin Med. 2020 Feb 9;9(2):476. doi: 10.3390/jcm9020476.
- Optimal Two-Stage Designs For Phase II Clinical TrialsLink provided by the sponsor.
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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.
Jae-Joon Yim, MD study director
Seoul National University Hospital
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 Vancomycin in people with Pneumonia, Staphylococcal and Methicillin-Resistant Staphylococcus Aureus, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 13 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 23 Apr 2019. 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 South Korea. 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?
clinical cure rate (time frame: within the first 30 days after 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 NCT01925066, which also lists 2 linked publications.
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 23 Apr 2019.