Cystic FibrosisPhase 2NCT01746095
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients
A Phase 2 study testing Vancomycin hydrochloride inhalation powder in people with Cystic Fibrosis, run by Savara Inc. at 38 sites in United States.
Trial summary
The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Vancomycin hydrochloride inhalation powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 38 sitesUnited States
- Study dates
- Mar 2013to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults ≥18 years old (and the legally authorized representatives of children ≥12 but <18 years old): Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form (ICF). Children ≥12 but <18 years old: Able to communicate with site personnel and to understand and voluntarily sign the Assent Form.
- Able and willing to comply with the protocol, including availability for all scheduled study visits.
- Have a confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following: a) Positive sweat chloride test (value ≥60 mEq/L), or b) Genotype with two mutations consistent with CF (ie, a mutation in each of the cystic fibrosis transmembrane conductance regulator [CFTR] genes).
- Be ≥12 years old at time of ICF/Assent Form signing.
- Have sputum culture positive for MRSA at Screening, with at least 10,000 CFUs/mL of MRSA.
- In addition to the screening sample, have at least two historical respiratory tract cultures (i.e., sputum and/or throat swab) positive for MRSA prior to Screening and evidence that the MRSA lung infection has persisted for at least 6 months prior to Screening.
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- Have forced expiratory volume in 1 second (FEV1) ≥30% and ≤100% of predicted that is normalized for age, gender, and height at Screening.
- Evidence, defined as one or both of the following, that the persistent MRSA lung infection is suspected to be causing health consequences.
- Have had at least one episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months from Screening. Initiation of treatment with intermittent inhaled anti-Pseudomonas therapy will not qualify as treatment with non-maintenance antibiotics.
- Requires anti-MRSA treatment as part of a maintenance regimen to prevent pulmonary exacerbations or other respiratory symptoms.
- Be able to perform all the techniques necessary to use the AeroVanc inhaler and measure lung function.
- Be able to produce expectorated sputum samples or be able and willing to undergo standardized sputum induction.
- Agree not to smoke from Screening through the end of the study.
- Female patients of child-bearing potential are eligible to participate in this study only if they are NOT pregnant or lactating, and if the patient is using a highly effective method of birth control.
- Patients with P. aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the investigator, stable despite the lack of such treatment. Patients on a Cayston based therapy must have received at least 2 cycles of Cayston prior to Baseline (can be 2 consecutive months or 2 cycles over 4 months).
Who cannot join
- Administration of any investigational drug or device within 28 days prior to ICF/Assent Form signing.
- Use of iv or inhaled anti-MRSA drugs within 28 days or oral anti-MRSA drugs within 14 days prior to Visit 2 (ie, randomization, Baseline and AeroVanc/placebo treatment initiation).
- A history of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome.
- History of severe cough/bronchospasm upon inhalation of dry powder inhalation product, or nebulized vancomycin.
- Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus [VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with minimum inhibitory concentration [MIC] ≥4 mcg/mL).
- Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone every other day, or equipotent doses of another corticosteroid.
Show all 20Show fewer
- History of sputum culture or throat swab culture yielding B. cepacia or gladioli in the previous two years, or nontuberculosis mycobacteria in the previous six months.
- An acute upper or lower respiratory infection, or pulmonary exacerbation within 7 days prior to Randomization.
- Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to ICF/Assent Form signing.
- Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night.
- Changes in physiotherapy technique or schedule within 7 days prior to ICF/Assent Form signing.
- History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation.
- A chest X-Ray at Screening with abnormalities indicating a significant acute finding (eg, pneumothorax, or pleural effusion).
- Lactating female or female with a positive pregnancy test result. All women of childbearing potential will be tested.
- Renal insufficiency, defined as creatinine clearance <50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation in children, at Screening.
- Diagnosed with clinically significant hearing loss.
- Abnormal liver function, defined as ≥4x upper limit of normal (ULN), of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT), or known cirrhosis at the time of Screening.
- Serum hematology or chemistry screening results which in the judgment of the Investigator would interfere with completion of the study.
- Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Other findings or medical history at screening that, in the Investigator's opinion, would compromise the safety of the patient or the quality of the study data.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Massachusetts General Hospital Pediatric Cystic Fibrosis Center
Boston, Massachusetts, 02114
Boston Children's Hospital Cystic Fibrosis Center
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Rainbow Babies and Children's Hospital / University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
The Children's Medical Center of Dayton
Dayton, Ohio, 45404
National Jewish Health
Denver, Colorado, 80206
Wayne State University, Harper Hospital, Children's Hospital of Michigan
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
The Cystic Fibrosis Center of Chicago
Glenview, Illinois, 60025
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Baylor College of Medicine and Texas Children's Hospital
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky Cystic Fibrosis Clinic
Lexington, Kentucky, 40536
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
Children's Hospital Los Angeles, Division of Pediatric Pulmonology
Los Angeles, California, 90027
University of Louisville
Louisville, Kentucky, 40202
University of Miami - Miller School of Medicine
Miami, Florida, 33136
Pulmonary Associates of Mobile
Mobile, Alabama, 36608
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Hofstra North Shore - Long Island Jewish School of Medicine
New Hyde Park, New York, 11040
Columbia University Medical Center
New York, New York, 10032
Santiago Reyes, MD
Oklahoma City, Oklahoma, 73112
Central Florida Pulmonary Group
Orlando, Florida, 32803
Nemours Children's Clinic and Hospital
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
University of Utah, Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, 84132
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
New Lung Associates, PA; Lung Transplant, Adult Cystic Fibrosis, and the Center for Advanced Lung Diseases, Tampa General Hospital
Tampa, Florida, 33606
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients
The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
Read the detailed description
This is a Phase 2a randomized, multicenter, double-blind, placebo-controlled, parallel group study to examine the safety and efficacy of AeroVanc in the treatment of persistent MRSA lung infection in CF patients. Pharmacokinetics will be evaluated in a subgroup by measuring plasma and sputum concentrations of vancomycin.
Prior to treatment, patients will be randomized to receive either AeroVanc twice daily (bid), or placebo bid. Patients will be stratified based on the presence of a Pseudomonas aeruginosa (P. aeruginosa) co-infection that is being treated with a chronic suppression regimen. Patients with P. aeruginosa co-infection can be on any chronic inhaled suppression regimen (or nothing if the patient is considered stable in the opinion of the investigator despite the lack of treatment). Regardless of treatment regimen, if there is an off month, screening should be scheduled so that AeroVanc or placebo administration can be given during this time. Patients with no off month should be screened so that the AeroVanc or placebo administration period coincides with a treatment cycle other than TOBI (e.g., Cayston or colistin). All patients must have at least a 24-hour washout period after stopping their anti-Pseudomonas therapy and prior to the Visit 2 (Baseline) pre-dose microbiology sputum sample. The AeroVanc or placebo treatment duration is 28 days, during which efficacy and safety parameters will be measured, and after which patients will be followed up for 56 days.
There will be two treatment cohorts in this study, each comprised of 40 randomized (1:1 active to placebo) and treated patients (adults ≥18 and children ≥12 years of age). In Cohort 1, patients will be enrolled and randomized to receive the 32 mg dose of AeroVanc bid or placebo bid. Prior to starting enrollment in Cohort 2, a safety evaluation will be carried out by the Data Monitoring Committee (DMC) based on treatment data from the first 20 patients in Cohort 1. Subject to the Sponsor's written communication of the DMC's opinion of acceptable safety, the dose for the active arm in Cohort 2 will be escalated to 64 mg bid. Optionally, the active arm for Cohort 2 may also be kept the same (32 mg bid), or reduced to 16 mg bid, depending on the outcome of the DMC's safety evaluation.
- Conditions
- Cystic Fibrosis
- Being tested
- Vancomycin hydrochloride inhalation powder, Placebo inhalation powder
- Keywords
- Cystic Fibrosis, MRSA, Methicillin-resistant Staphylococcus aureus, Lung infection, AeroVanc, Vancomycin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin hydrochloride inhalation powderDrug
Also called AeroVanc
There will be two treatment cohorts in this study, each comprised of 40 randomized (1:1 active to placebo) and treated patients (adults ≥18 and children ≥12 years of age). In Cohort 1, patients will be enrolled and randomized to receive the 32 mg dose of AeroVanc bid or placebo bid. Prior to starting enrollment in Cohort 2, a safety evaluation will be carried out by the Data Monitoring Committee (DMC) based on treatment data from the first 20 patients in Cohort 1. Subject to the Sponsor's written communication of the DMC's opinion of acceptable safety, the dose for the active arm in Cohort 2 will be escalated to 64 mg bid. Optionally, the active arm for Cohort 2 may also be kept the same (32 mg bid), or reduced to 16 mg bid, depending on the outcome of the DMC's safety evaluation.
Placebo inhalation powderDrug
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin hydrochloride inhalation powder | Experimental | 32 or 64 mg twice daily (BID) Receives: Drug: Vancomycin hydrochloride inhalation powder |
| Placebo inhalation powder | Placebo comparator | Matching placebo inhalation powder BID Receives: Drug: Placebo inhalation powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in MRSA Sputum Density.
Change from Baseline at Day 29 of the dosing period (start of AeroVanc/Placebo administration is considered Day 1 of the dosing period) in the number of MRSA colony forming units (CFU) in sputum culture.
Measured: Day 29 of treatment period
Secondary outcomes (9)
Change From Baseline in MRSA Sputum Density.
Measured: Day 8 of treatment period
Change From Baseline in MRSA Sputum Density.
Measured: Day 15 of treatment period
Change From Baseline in FEV1
Absolute change from baseline in FEV1 percent predicted
Measured: Day 29 of treatment period
Change From Baseline in FVC
Absolute change from baseline in FVC percent predicted
Measured: Day 29 of treatment period
Change From Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD-CRISS) Scores
Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD) Chronic Respiratory Infection Symptom Scores (CRISS). The minimum score is 0 and the maximum is 100, where a higher score means a worse outcome.
Measured: Day 29 of treatment period
Time From Start of Dosing to First Administration of Other Antimicrobial Medications (Oral, Intravenous and/or Inhaled) Due to Respiratory Symptoms.
Measured: Entire study: Day 1 of treatment period through 8 week post-treatment follow up visit
Time From Start of Dosing to Exacerbation of Signs/Symptoms (Fuchs Criteria).
Measured: Entire study: Day 1 of treatment period through 8 week post-treatment follow up visit
Change From Baseline in High Sensitivity CRP
Measured: Day 29 of the dosing period
Change From Baseline in Blood Neutrophils
Measured: Day 29 of the dosing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savara Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc., Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Elliott Dasenbrook, M.D., MHS, Principal investigator, Case Western Reserve University School of Medicine and Rainbow Babies and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746095
- Sponsor's protocol ID
- SAV005-02
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2012
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.
PubMed 36511181
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT01746095
- Acronym / sponsor ID
- SAV005-02
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, MRSA, Methicillin-resistant Staphylococcus aureus, Lung infection, AeroVanc, Vancomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Savara Inc.Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc., Cystic Fibrosis Foundation
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Posted 13 Jan 2020
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 AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
Detailed description
This is a Phase 2a randomized, multicenter, double-blind, placebo-controlled, parallel group study to examine the safety and efficacy of AeroVanc in the treatment of persistent MRSA lung infection in CF patients. Pharmacokinetics will be evaluated in a subgroup by measuring plasma and sputum concentrations of vancomycin.
Prior to treatment, patients will be randomized to receive either AeroVanc twice daily (bid), or placebo bid. Patients will be stratified based on the presence of a Pseudomonas aeruginosa (P. aeruginosa) co-infection that is being treated with a chronic suppression regimen. Patients with P. aeruginosa co-infection can be on any chronic inhaled suppression regimen (or nothing if the patient is considered stable in the opinion of the investigator despite the lack of treatment). Regardless of treatment regimen, if there is an off month, screening should be scheduled so that AeroVanc or placebo administration can be given during this time. Patients with no off month should be screened so that the AeroVanc or placebo administration period coincides with a treatment cycle other than TOBI (e.g., Cayston or colistin). All patients must have at least a 24-hour washout period after stopping their anti-Pseudomonas therapy and prior to the Visit 2 (Baseline) pre-dose microbiology sputum sample. The AeroVanc or placebo treatment duration is 28 days, during which efficacy and safety parameters will be measured, and after which patients will be followed up for 56 days.
There will be two treatment cohorts in this study, each comprised of 40 randomized (1:1 active to placebo) and treated patients (adults ≥18 and children ≥12 years of age). In Cohort 1, patients will be enrolled and randomized to receive the 32 mg dose of AeroVanc bid or placebo bid. Prior to starting enrollment in Cohort 2, a safety evaluation will be carried out by the Data Monitoring Committee (DMC) based on treatment data from the first 20 patients in Cohort 1. Subject to the Sponsor's written communication of the DMC's opinion of acceptable safety, the dose for the active arm in Cohort 2 will be escalated to 64 mg bid. Optionally, the active arm for Cohort 2 may also be kept the same (32 mg bid), or reduced to 16 mg bid, depending on the outcome of the DMC's safety evaluation.
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 |
|---|---|---|
| Vancomycin hydrochloride inhalation powder | Experimental | Drug: Vancomycin hydrochloride inhalation powder32 or 64 mg twice daily (BID) |
| Placebo inhalation powder | Placebo comparator | Drug: Placebo inhalation powderMatching placebo inhalation powder BID |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Adults ≥18 years old (and the legally authorized representatives of children ≥12 but <18 years old): Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form (ICF). Children ≥12 but <18 years old: Able to communicate with site personnel and to understand and voluntarily sign the Assent Form.
- Able and willing to comply with the protocol, including availability for all scheduled study visits.
- Have a confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following: a) Positive sweat chloride test (value ≥60 mEq/L), or b) Genotype with two mutations consistent with CF (ie, a mutation in each of the cystic fibrosis transmembrane conductance regulator [CFTR] genes).
- Be ≥12 years old at time of ICF/Assent Form signing.
- Have sputum culture positive for MRSA at Screening, with at least 10,000 CFUs/mL of MRSA.
Key exclusion criteria (20 listed)
- Administration of any investigational drug or device within 28 days prior to ICF/Assent Form signing.
- Use of iv or inhaled anti-MRSA drugs within 28 days or oral anti-MRSA drugs within 14 days prior to Visit 2 (ie, randomization, Baseline and AeroVanc/placebo treatment initiation).
- A history of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome.
- History of severe cough/bronchospasm upon inhalation of dry powder inhalation product, or nebulized vancomycin.
- Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus [VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with minimum inhibitory concentration [MIC] ≥4 mcg/mL).
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 hydrochloride inhalation powderAlso: AeroVancThere will be two treatment cohorts in this study, each comprised of 40 randomized (1:1 active to placebo) and treated patients (adults ≥18 and children ≥12 years of age). In Cohort 1, patients will be enrolled and randomized to receive the 32 mg dose of AeroVanc bid or placebo bid. Prior to starting enrollment in Cohort 2, a safety evaluation will be carried out by the Data Monitoring Committee (DMC) based on treatment data from the first 20 patients in Cohort 1. Subject to the Sponsor's written communication of the DMC's opinion of acceptable safety, the dose for the active arm in Cohort 2 will be escalated to 64 mg bid. Optionally, the active arm for Cohort 2 may also be kept the same (32 mg bid), or reduced to 16 mg bid, depending on the outcome of the DMC's safety evaluation. | Drug | Vancomycin hydrochloride inhalation powder |
| Placebo inhalation powder | Drug | Placebo inhalation powder |
Primary outcome
Change From Baseline in MRSA Sputum Density.
Time frame: Day 29 of treatment period
Change from Baseline at Day 29 of the dosing period (start of AeroVanc/Placebo administration is considered Day 1 of the dosing period) in the number of MRSA colony forming units (CFU) in sputum culture.
9 secondary outcomes
Change From Baseline in MRSA Sputum Density.
Time frame: Day 8 of treatment period
Change From Baseline in MRSA Sputum Density.
Time frame: Day 15 of treatment period
Change From Baseline in FEV1
Time frame: Day 29 of treatment period
Change From Baseline in FVC
Time frame: Day 29 of treatment period
Change From Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD-CRISS) Scores
Time frame: Day 29 of treatment period
Time From Start of Dosing to First Administration of Other Antimicrobial Medications (Oral, Intravenous and/or Inhaled) Due to Respiratory Symptoms.
Time frame: Entire study: Day 1 of treatment period through 8 week post-treatment follow up visit
Time From Start of Dosing to Exacerbation of Signs/Symptoms (Fuchs Criteria).
Time frame: Entire study: Day 1 of treatment period through 8 week post-treatment follow up visit
Change From Baseline in High Sensitivity CRP
Time frame: Day 29 of the dosing period
Change From Baseline in Blood Neutrophils
Time frame: Day 29 of the dosing period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36511181Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.
- CFF.org - "MRSA and Cystic Fibrosis"Link 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.
Elliott Dasenbrook, M.D., MHS principal investigator
Case Western Reserve University School of Medicine and Rainbow Babies and Children's Hospital
38 sites 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 hydrochloride inhalation powder in people with Cystic Fibrosis, run by Savara Inc. at 38 sites 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 15 inclusion and 20 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites 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?
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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in MRSA Sputum Density. (time frame: Day 29 of treatment period). 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 NCT01746095, 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 13 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.