Cystic FibrosisPhase 1NCT01509339
Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis
A Phase 1 study testing Vancomycin in people with Cystic Fibrosis and Methicillin-resistant Staphylococcus Aureus, run by Case Western Reserve University at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Methicillin-resistant Staphylococcus Aureus
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 23 Dec 2021
- Phase
- 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
- Male or female ≥ 18 years of age.
- Confirmed diagnosis of CF based on the following criteria:
- positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or
- a genotype with two identifiable mutations consistent with CF or abnormal NPD, and
- one or more clinical features consistent with the CF phenotype.
- Chronic sputum producer able to spontaneously produce sputum
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- FEV1 > 40% of predicted normal for age, gender, and height
- Previous use of any inhaled antibiotics within the last year
- Ability to provide written informed consent
- Ability to adhere to the protocol
Who cannot join
- Use of inhaled or intravenous vancomycin within two weeks of the study visit
- Known history of intolerance to inhaled vancomycin or inhaled albuterol.
- Known history of hypersensitivity to vancomycin or other glycopeptide antibiotics
- History of sputum culture with Burkholderia cepacia complex in the last two years.
- Pregnancy
- Woman who are lactating and not willing to stop nursing on the day of the study visit and the subsequent 48 hours.
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- Current use of oral corticosteroids in doses exceeding the equivalent of 10mg of prednisone a day or 20mg of prednisone every other day.
- Patients not willing to hold other inhaled antibiotics (for example TOBI, Cayston, or Colistin) for at least 2 days prior to the study visit.
- Patients not willing to hold loop diuretics (i.e. furosemide, torsemide, ethacrynic acid) on the morning of the study visit.
- History of ABPA or reactive airways disease that has required treatment within the last year.
- Creatinine greater than 2.0 mg/dL within the last year.
- Oxygen saturation ≤ 92% on room air.
- History of patient reported hearing loss
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or adherence to the protocol.
- History of or listed for solid organ or hematological transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainbow Babies and Children's Hospital, Univeristy Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.
Read the detailed description
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in patients with cystic fibrosis has increased dramatically over the last decade. Epidemiologic evidence suggests that persistent infection with MRSA may result in an increased rate of decline in FEV1 and shortened survival. Treatment of MRSA is a top priority. Inhaled antibiotics offer the advantage of high concentrations of antibiotic at the site of infection (the airway) while minimizing systemic side effects. Vancomycin is a glycopeptide antibiotic that has activity against MRSA. Anecdotal and retrospective peer-reviewed studies have demonstrated that inhaled vancomycin is safe and potentially effective in patients with cystic fibrosis and MRSA airway infection. Data evaluating the pharmacokinetics of vancomycin in sputum are needed before pursuing treatment trials.
- Being tested
- Vancomycin
- Keywords
- Vancomycin, Inhalation, Nebulization, Pharmacokinetics
- Medical subject headings
- Cystic Fibrosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Nebulized vancomycin, Inhaled Vancomycin, Vancomycin for inhalation, Aerosolized Vancomycin
250 mg vancomycin in 5cc sterile water will be inhaled once. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin for Inhalation | Experimental | 250 mg vancomycin in 5cc sterile water will be inhaled once. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Pharmacokinetic analysis will be performed with non-compartmental methods. The area under the curve for sputum vancomycin will be determined.
Measured: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin
Secondary outcomes (8)
Change in FEV1% Predicted
Change in FEV1% predicted from baseline to 30 minutes after completion of inhaled vancomycin
Measured: 30 minutes
Change in Patient Symptoms
Patient's respiratory symptoms and potential side effects from inhaling vancomycin will be queried using a questionnaire prior to inhaling vancomycin, at 15 ±10 minutes, and 4 ± 1 hour after completing inhaled vancomycin.
Measured: 6 hours
Change in Sputum Cell Counts
Change in sputum cell counts (i.e. eosinophils) between baseline and six hours after completion of inhaled vancomycin.
Measured: 6 hours
Serum Vancomycin Peak Concentration
Serum vancomycin peak concentration 60 minutes after completion of inhaled vancomycin.
Measured: 60 minutes
Oxygen Saturation
Continuous oxygen saturation monitoring to be continued throughout vancomycin inhalation and for 5 minutes after inhalation
Measured: 5 minutes
Adverse Events
Information regarding occurrence of adverse events will be captured throughout the study. Duration (start and stop times), severity/grade, outcome, treatment and relation to study medication will be recorded
Measured: 6 hours
Maximum Concentration
Pharmacokinetic analysis will be performed with non-compartmental methods. The maximum concentration of sputum vancomycin will be determined.
Measured: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin
Time to Peak Concentration
Pharmacokinetic analysis will be performed with non-compartmental methods. The time to peak concentration for sputum vancomycin will be determined.
Measured: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2012 (estimated)
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Why it stopped: Lab unable to measure vancomycin levels in Sputum
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Elliott Dasenbrook, Case Western Reserve University
- Investigators
- Elliott C Dasenbrook, MD MHS, Principal investigator, Case Western Reserve University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509339
- Sponsor's protocol ID
- iVCM 1.0
- Status last verified
- Dec 2021
- First submitted
- 9 Jan 2012
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dasenbrook EC, Checkley W, Merlo CA, Konstan MW, Lechtzin N, Boyle MP. Association between respiratory tract methicillin-resistant Staphylococcus aureus and survival in cystic fibrosis. JAMA. 2010 Jun 16;303(23):2386-92. doi: 10.1001/jama.2010.791.
PubMed 20551409Dasenbrook EC, Merlo CA, Diener-West M, Lechtzin N, Boyle MP. Persistent methicillin-resistant Staphylococcus aureus and rate of FEV1 decline in cystic fibrosis. Am J Respir Crit Care Med. 2008 Oct 15;178(8):814-21. doi: 10.1164/rccm.200802-327OC. Epub 2008 Jul 31.
PubMed 18669817Dasenbrook EC. Update on methicillin-resistant Staphylococcus aureus in cystic fibrosis. Curr Opin Pulm Med. 2011 Nov;17(6):437-41. doi: 10.1097/MCP.0b013e32834b95ed.
PubMed 21918450Doe SJ, McSorley A, Isalska B, Kearns AM, Bright-Thomas R, Brennan AL, Webb AK, Jones AM. Patient segregation and aggressive antibiotic eradication therapy can control methicillin-resistant Staphylococcus aureus at large cystic fibrosis centres. J Cyst Fibros. 2010 Mar;9(2):104-9. doi: 10.1016/j.jcf.2009.11.009. Epub 2010 Jan 3.
PubMed 20051329
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01509339
- Acronym / sponsor ID
- iVCM 1.0
- Keywords
- Vancomycin, Inhalation, Nebulization, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lab unable to measure vancomycin levels in Sputum
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Jan 2012 (estimated)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 13 Jan 2012 (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 the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.
Detailed description
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in patients with cystic fibrosis has increased dramatically over the last decade. Epidemiologic evidence suggests that persistent infection with MRSA may result in an increased rate of decline in FEV1 and shortened survival. Treatment of MRSA is a top priority. Inhaled antibiotics offer the advantage of high concentrations of antibiotic at the site of infection (the airway) while minimizing systemic side effects. Vancomycin is a glycopeptide antibiotic that has activity against MRSA. Anecdotal and retrospective peer-reviewed studies have demonstrated that inhaled vancomycin is safe and potentially effective in patients with cystic fibrosis and MRSA airway infection. Data evaluating the pharmacokinetics of vancomycin in sputum are needed before pursuing treatment trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancomycin for Inhalation | Experimental | Drug: Vancomycin250 mg vancomycin in 5cc sterile water will be inhaled once. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female ≥ 18 years of age.
- Confirmed diagnosis of CF based on the following criteria:
- Chronic sputum producer able to spontaneously produce sputum
- FEV1 > 40% of predicted normal for age, gender, and height
- Previous use of any inhaled antibiotics within the last year
Key exclusion criteria (15 listed)
- Use of inhaled or intravenous vancomycin within two weeks of the study visit
- Known history of intolerance to inhaled vancomycin or inhaled albuterol.
- Known history of hypersensitivity to vancomycin or other glycopeptide antibiotics
- History of sputum culture with Burkholderia cepacia complex in the last two years.
- 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 |
|---|---|---|
| VancomycinAlso: Nebulized vancomycin, Inhaled Vancomycin, Vancomycin for inhalation, Aerosolized Vancomycin250 mg vancomycin in 5cc sterile water will be inhaled once. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system. | Drug | Vancomycin for Inhalation |
Primary outcome
Area Under Curve (AUC)
Time frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin
Pharmacokinetic analysis will be performed with non-compartmental methods. The area under the curve for sputum vancomycin will be determined.
8 secondary outcomes
Change in FEV1% Predicted
Time frame: 30 minutes
Change in Patient Symptoms
Time frame: 6 hours
Change in Sputum Cell Counts
Time frame: 6 hours
Serum Vancomycin Peak Concentration
Time frame: 60 minutes
Oxygen Saturation
Time frame: 5 minutes
Adverse Events
Time frame: 6 hours
Maximum Concentration
Time frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin
Time to Peak Concentration
Time frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Background: PubMed 20551409Dasenbrook EC, Checkley W, Merlo CA, Konstan MW, Lechtzin N, Boyle MP. Association between respiratory tract methicillin-resistant Staphylococcus aureus and survival in cystic fibrosis. JAMA. 2010 Jun 16;303(23):2386-92. doi: 10.1001/jama.2010.791.
- Background: PubMed 18669817Dasenbrook EC, Merlo CA, Diener-West M, Lechtzin N, Boyle MP. Persistent methicillin-resistant Staphylococcus aureus and rate of FEV1 decline in cystic fibrosis. Am J Respir Crit Care Med. 2008 Oct 15;178(8):814-21. doi: 10.1164/rccm.200802-327OC. Epub 2008 Jul 31.
- Background: PubMed 21918450Dasenbrook EC. Update on methicillin-resistant Staphylococcus aureus in cystic fibrosis. Curr Opin Pulm Med. 2011 Nov;17(6):437-41. doi: 10.1097/MCP.0b013e32834b95ed.
- Background: PubMed 20051329Doe SJ, McSorley A, Isalska B, Kearns AM, Bright-Thomas R, Brennan AL, Webb AK, Jones AM. Patient segregation and aggressive antibiotic eradication therapy can control methicillin-resistant Staphylococcus aureus at large cystic fibrosis centres. J Cyst Fibros. 2010 Mar;9(2):104-9. doi: 10.1016/j.jcf.2009.11.009. Epub 2010 Jan 3.
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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.
Elliott C Dasenbrook, MD MHS principal investigator
Case Western Reserve University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vancomycin in people with Cystic Fibrosis and Methicillin-resistant Staphylococcus Aureus, run by Case Western Reserve 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 10 inclusion and 15 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: withdrawn, as of the sponsor's last update on 12 Jan 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area Under Curve (AUC) (time frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin). 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 NCT01509339, which also lists 4 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 12 Jan 2022.