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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 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.

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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.

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

FieldValue
Enrollment Target 87 participants
Start Date 2013-03
Est. Completion 2014-11
Phase Phase 2

Sponsor

Savara

5 total trials

What the Registry Record Tells You About NCT01746095

The ClinicalTrials.gov registry entry for NCT01746095 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (51% lower). The listed sponsor is Savara, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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