OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

221

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

August 23, 2018

Study Completion Date

August 23, 2018

Conditions
Cystic Fibrosis
Interventions
DRUG

azithromycin

3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months

DRUG

placebo

3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months

DRUG

Tobramycin solution for inhalation

300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months

Trial Locations (45)

10032

CFF Care Center & Pediatric Program Columbia University, New York

10595

CFF Care Center New York Medical College, Valhalla

13210

CFF Care Center & Pediatric Program SUNY Upstate Medical University, Syracuse

15224

CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh, Pittsburgh

17033

CFF Care Center & Pediatric Program Hershey Medical Center, Hershey

23298

CFF Care Center Medical College of Virginia, Richmond

23507

CFF Care Center & Pediatric Program Children's Hospital of the King's Daughters, Norfolk

27599

CFF Care Center & Pediatric Program University of North Carolina at Chapel Hill, Chapel Hill

30324

CFF Care Center & Pediatric Program Emory University, Atlanta

30342

CFF Affiliate Program Children's Healthcare of Atlanta, Atlanta

32207

CFF Care Center & Pediatric Program Nemours Children's Clinic - Jacksonville, Jacksonville

33701

CFF Care Center & Pediatric Program All Children's Hospital, St. Petersburg

38103

CFF Care Center & Pediatric Program University of Tennessee, Memphis

43205

CFF Care Center & Pediatric Program Nationwide Children's Hospital, Columbus

44106

CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospital, Cleveland

44308

CFF Care Center & Pediatric Program Akron Children's Hospital, Akron

45229

CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center, Cincinnati

45404

CFF Care Center & Pediatric Program The Children's Medical Center, Dayton

48201

CFF Care Center & Pediatric Program Children's Hospital of Michigan, Detroit

52242

CFF Care Center & Pediatric Program University of Iowa, Iowa City

53226

CFF Care Center & Pediatric Program Children's Hospital of Wisconsin, Milwaukee

53792

CFF Care Center & Pediatric Program University of Wisconsin, Madison

57117

CFF Care Center & Pediatric Program Sanford USD Medical Center, Sioux Falls

63104

CFF Care Center & Pediatric Program Cardinal Glennon Children's Hospital/Saint Louis University, St Louis

63110

CFF Care Center & Pediatric Program St. Louis Children's Hospital, St Louis

64108

CFF Care Center The Children's Mercy Hospital, Kansas City

68198

CFF Care Center & Pediatric Program University of Nebraska Medical Center, Omaha

72202

CFF Care Center & Pediatric Program Arkansas Children's Hospital, Little Rock

78723

CFF Care Center & Pediatric Program Dell Children's Medical Center of Central Texas, Austin

80045

CFF Care Center & Pediatric Program Children's Hospital Colorado, Aurora

83712

CFF Care Center St. Luke's CF Clinic, Boise

84132

University of Utah, Salt Lake City

85724

CFF Care Center Arizona Health Science Center, Tucson

90027

Childrens Hospital Los Angeles, Los Angeles

94304

CFF Care Center & Pediatric Program Stanford University, Palo Alto

97239

CFF Care Center & Pediatric Program Oregon Health & Sciences University, Portland

98145

CFF Care Center & Pediatric Program Seattle Children's Hospital, Seattle

99519-6604

CFF Affiliate Program Providence Medical Center, Anchorage

06520

CFF Care Center & Pediatric Program Yale University, New Haven

60611-2605

CFF Care Center & Pediatric Program Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

46202-5271

CFF Care Center & Pediatric Program Riley Hospital for Children, Indianapolis

04102

CFF Care Center & Pediatric Program Maine Medical Center, Portland

02115

CFF Care Center & Pediatric Program Children's Hospital Boston, Boston

48109-5212

CFF Care Center & Pediatric Program University of Michigan, Ann Arbor

07740

CFF Care Center & Pediatric Program Monmouth Medical Center, Long Branch

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Bonnie Ramsey

OTHER

NCT02054156 - OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis | Biotech Hunter | Biotech Hunter