Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01746095 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients
A Phase 2 study of Cystic Fibrosis, sponsored by Savara.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
- 20
- Study locations
NCT01746095: Completed Phase 2 study of Cystic Fibrosis, sponsored by Savara.
NCT01746095 is a Phase 2 study of Cystic Fibrosis that has completed, run by Savara. The registered enrollment target is 87 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01746095, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Savara.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Vancomycin hydrochloride inhalation powder
- DRUG Placebo inhalation powder
Study Locations (20)
Florida
- Joe DiMaggio Children's Hospital - Hollywood
- University of Miami - Miller School of Medicine - Miami
- Central Florida Pulmonary Group - Orlando
- Nemours Children's Clinic and Hospital - Orlando
- New Lung Associates, PA; Lung Transplant, Adult Cystic Fibrosis, and the Center for Advanced Lung Diseases, Tampa General Hospital - Tampa
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- Northwestern University Feinberg School of Medicine - Chicago
- The Cystic Fibrosis Center of Chicago - Glenview
Kentucky
- University of Kentucky Cystic Fibrosis Clinic - Lexington
- University of Louisville - Louisville
Massachusetts
- Massachusetts General Hospital Pediatric Cystic Fibrosis Center - Boston
- Boston Children's Hospital Cystic Fibrosis Center - Boston
Alabama
- Pulmonary Associates of Mobile - Mobile
Arkansas
- University of Arkansas for Medical Science - Little Rock
California
- Children's Hospital Los Angeles, Division of Pediatric Pulmonology - Los Angeles
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01746095 record still lists
NCT01746095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Vancomycin hydrochloride inhalation powder is the first listed.
NCT01746095 names 20 study sites across 12 states, led by Florida, Illinois, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01746095 about?
NCT01746095 is a clinical study titled "Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA 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.
What is the current status of trial NCT01746095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2013-03. Estimated completion is 2014-11.
What conditions does trial NCT01746095 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01746095?
The interventions under investigation include: Vancomycin hydrochloride inhalation powder (DRUG), Placebo inhalation powder (DRUG).
Who is sponsoring clinical trial NCT01746095?
This trial is sponsored by Savara, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01746095 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01746095's enrollment target sits among peer trials
87 68th of 169 higher than 102 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
RECRUITING · Phase 2
-
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
RECRUITING · Phase 2
-
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients with Cystic Fibrosis
RECRUITING · Phase 2
-
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
RECRUITING · Phase 2
-
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
RECRUITING · Phase 2
-
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03292601 · 87 participants · NA
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
- NCT04291105 · 87 participants · Phase 2
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
- NCT04565795 · 87 participants · NA
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
- NCT05607004 · 87 participants · Phase 2
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia