AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

September 20, 2017

Primary Completion Date

July 28, 2020

Study Completion Date

January 15, 2021

Conditions
MRSACystic Fibrosis
Interventions
DRUG

Vancomycin inhalation powder

100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \>21 years old) for 24 weeks during Period 1.

DRUG

Placebo inhalation powder

100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \>21 years old) for 24 weeks during Period 1.

DRUG

Vancomycin inhalation powder

In the 24-week Period 2, all participants are to be treated with open-label vancomycin inhalation powder.

Trial Locations (71)

10032

Columbia University Medical Center, New York

11042

Northwell Health, Div of Pulmonary, Critical Care & Sleep Medicine, New Hyde Park

12208

Albany Medical College, Albany

15224

Children's Hospital of Pittsburgh of UPMCU, Pittsburgh

17033

Penn State Children's Hospital, Hershey

19104

University of Pennsylvania, Philadelphia

20010

Children's National Medical Center, Washington D.C.

22908

University of Virginia Health System, Cystic Fibrosis Center, Charlottesville

26506

West Virginia University, Morgantown

27157

Wake Forest School of Medicine, Winston-Salem

27710

Duke University Medical Center, Durham

28203

Levine Children's Hospital - Atrium Health, Charlotte

29425

Medical University of South Carolina (MUSC), Charleston

30342

Children's Health Care of Atlanta at Scottish Rite, Atlanta

30912

Augusta Univ Cystic Fibrosis Center, Augusta

32207

Nemours Childrens Specialty Care, Jacksonville

32514

Nemours Children's Specialty Care, Pensacola

32610

University of Florida Pediatrics, Gainesville

32803

Central Florida Pulmonary Group, Orlando

32806

Arnold Palmer Hospital Pulmonary and Sleep Medical Institute Orlando Health, Inc, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Memorial Healthcare System, Hollywood

33136

University of Miami Bachelor Children's Hospital, Miami

33701

Johns Hopkins All Children's Hospital, St. Petersburg

36608

Pulmonary Associates of Mobile, Mobile

38103

UTHSC Lebonheur Children's Hospital, Memphis

40202

University of Louisville Kosair Charities Pediatric Clinical Research Unit, Louisville

43205

The Research Institute at Nationwide Children's Hospital, Columbus

43606

Toledo Children's Hospital CF Center, Toledo

44106

University Hospital Cleveland Medical Center, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

48109

University of Michigan Health System, Ann Arbor

48201

Wayne State University (HUH), Detroit

52242

University of Iowa Department of Pediatrics, Iowa City

57105

Sanford Childrens Specialty Clinic, Sioux Falls

60025

Chicago CF Care Specialists, Glenview

60053

NorthSurburban Pulmonary Specialists, Morton Grove

63104

Cardinal Glennon Children's Hospital /Saint Louis University, St Louis

63110

Washington University, St Louis

64108

Children's Mercy, Kansas City

66160

University of Kansas, Kansas City

67214

Via Christi Health Systems CF Clinic, Wichita

68198

University of Nebraska Medical Center, Omaha

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Science Center - Pediatric Pulmonary & CF Center, Oklahoma City

75235

Children's Medical Center Cystic Fibrosis Clinic, Dallas

75708

The University of Texas Health Science Center at Tyler, Tyler

76104

Cook Children Medical Center, Fort Worth

77030

Texas Children's Hospital, Houston

78723

Austin Children's Chest Associates, Austin

80045

Children's Hospital Colorado, Aurora

80206

National Jewish Health Adult Cystic Fibrosis Center, Denver

84132

University of Utah Health Sciences Center, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

87131

University of New Mexico Pediatric/Pulmonary, Albuquerque

90027

Children's Hospital Los Angeles, Los Angeles

90033

University of Southern California Keck Medical Center of USC, Los Angeles

90806

Miller Childrens Hospital MemorialCare Health System Pediatric Pulmonology, Long Beach

95817

UC Davis Medical Center, Sacramento

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

99204

Providence Medical Research Center, Spokane

04102

Maine Medical Partners Pediatric Specialty Care, Portland

02115

Boston Children's Hospital, Boston

07960

Morristown Medical Center, Morristown

08901

Rutgers-Robert Wood Johnson Medical School, New Brunswick

05446

University Vermont Medical Center Vermont Lung Center, Colchester

V6H 3V4

British Columbia Children's Hospital, Vancouver

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

Savara Inc.

INDUSTRY

NCT03181932 - AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis | Biotech Hunter | Biotech Hunter