Actively Recruiting

Phase 4
Age: 6Years +
All Genders
NCT05548283

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Led by Chris Goss · Updated on 2024-08-26

730

Participants Needed

60

Research Sites

186 weeks

Total Duration

On this page

Sponsors

C

Chris Goss

Lead Sponsor

U

University of Washington

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation: * Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)? * Is taking one type of antibiotic just as good as taking two types?

CONDITIONS

Official Title

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Who Can Participate

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All genders 6 years of age or older at Visit 1
  • Confirmed diagnosis of cystic fibrosis
  • Clinician plans to treat current pulmonary exacerbation with a 14-day course of intravenous antibiotics
  • At least one positive Pseudomonas aeruginosa culture within two years before Visit 1
Not Eligible

You will not qualify if you...

  • Participant is pregnant
  • Known kidney problems or history of organ transplant
  • Received intravenous antibiotic treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks before Visit 1
  • Used investigational therapies, new CFTR modulators, or treatment for nontuberculous mycobacteria within 4 weeks before Visit 1
  • History of allergic reaction or ear/vestibular toxicity to aminoglycoside antibiotics
  • Received more than one day of intravenous aminoglycosides for the current pulmonary exacerbation before Visit 1

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 60 locations

1

The Children's Hospital Alabama, University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Tucson Cystic Fibrosis Center

Tucson, Arizona, United States, 85724

Actively Recruiting

3

University of California San Diego

La Jolla, California, United States, 92093

Actively Recruiting

4

Long Beach Memorial Medical Center

Long Beach, California, United States, 90806

Actively Recruiting

5

CHOC Children's Hospital

Orange, California, United States, 92868

Actively Recruiting

6

University of California at Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

7

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Not Yet Recruiting

8

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

9

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States, 33021

Actively Recruiting

10

Nemours Children's Clinic

Jacksonville, Florida, United States, 32207

Actively Recruiting

11

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

12

All Children's Hospital

St. Petersburg, Florida, United States, 33701

Actively Recruiting

13

Emory University

Atlanta, Georgia, United States, 30327

Actively Recruiting

14

Saint Luke's Cystic Fibrosis Center of Idaho

Boise, Idaho, United States, 83702

Actively Recruiting

15

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

16

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

17

OSF Saint Francis Medical Center

Peoria, Illinois, United States, 61637

Actively Recruiting

18

Indiana University Medical Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

19

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Actively Recruiting

20

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

21

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

22

University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

23

Maine Medical Center

Portland, Maine, United States, 04102

Actively Recruiting

24

John Hopkins Hospital

Baltimore, Maryland, United States, 21205

Actively Recruiting

25

Boston Children's Hospital, Brigham & Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

26

University of Massachusetts Memorial Health Care

Worcester, Massachusetts, United States, 01655

Actively Recruiting

27

University of Michigan, Michigan Medicine

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

28

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

29

SSM Health Cardinal Glennon Children's Hospital

St Louis, Missouri, United States, 63104

Actively Recruiting

30

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

31

Billings Clinic

Billings, Montana, United States, 59101

Actively Recruiting

32

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

33

Morristown Medical Center

Morristown, New Jersey, United States, 07960

Actively Recruiting

34

Rutgers - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

35

Lenox Hill Hospital Cystic Fibrosis Center

New York, New York, United States, 10003

Actively Recruiting

36

Children's Hospital of New York

New York, New York, United States, 10032

Actively Recruiting

37

New York Medical College at Westchester Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

38

Children's Hospital Medical Center of Akron

Akron, Ohio, United States, 44308

Actively Recruiting

39

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

40

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45267

Actively Recruiting

41

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44146

Actively Recruiting

42

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

43

Dayton Children's Hospital

Dayton, Ohio, United States, 45404

Actively Recruiting

44

Toledo Children's Hospital

Toledo, Ohio, United States, 43606

Actively Recruiting

45

Oklahoma Cystic Fibrosis Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

46

Oregon Health Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

47

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

48

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

49

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

50

Vanderbilt Children's Hospital

Nashville, Tennessee, United States, 37232

Actively Recruiting

51

University of Texas Southwestern / Children's Health

Dallas, Texas, United States, 75207

Actively Recruiting

52

University of Texas Southwestern

Dallas, Texas, United States, 75390

Actively Recruiting

53

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

Actively Recruiting

54

Virginia Commonwealth University

Richmond, Virginia, United States, 23219

Actively Recruiting

55

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

56

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

57

Providence Medical Group, Cystic Fibrosis Clinic

Spokane, Washington, United States, 99204

Actively Recruiting

58

West Virginia University - Morgantown

Morgantown, West Virginia, United States, 26507

Actively Recruiting

59

University of Wisconsin

Madison, Wisconsin, United States, 53792

Actively Recruiting

60

University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)

Calgary, Alberta, Canada, T2N4N1

Actively Recruiting

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Research Team

R

Rachael Buckingham, BS

CONTACT

B

Barbra Fogarty

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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