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Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)

Primary Purpose

Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Beta-lactam antibiotic
Aminoglycoside
Sponsored by
Chris Goss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All genders ≥ 6 years of age at Visit 1
  • Documentation of a CF diagnosis
  • Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials
  • At least one documented Pa positive culture within two years prior to Visit 1

Exclusion Criteria:

  • Participant is not pregnant
  • No known renal impairment or history of solid organ transplantation
  • No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
  • No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1
  • No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
  • No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1

Sites / Locations

  • The Children's Hospital Alabama, University of Alabama at BirminghamRecruiting
  • Tucson Cystic Fibrosis Center
  • University of California San Diego
  • Long Beach Memorial Medical CenterRecruiting
  • CHOC Children's HospitalRecruiting
  • University of California at Davis Medical Center
  • Children's National Medical Center
  • University of Florida
  • Joe DiMaggio Children's Hospital
  • Nemours Children's Clinic
  • University of Miami
  • All Children's HospitalRecruiting
  • Emory University
  • Saint Luke's Cystic Fibrosis Center of IdahoRecruiting
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Northwestern University
  • OSF Saint Francis Medical Center
  • Indiana University Medical CenterRecruiting
  • Riley Hospital for Children
  • University of Iowa
  • University of Kansas Medical Center
  • University of Louisville
  • Maine Medical CenterRecruiting
  • John Hopkins Hospital
  • Boston Children's Hospital, Brigham & Women's Hospital
  • University of Massachusetts Memorial Health CareRecruiting
  • University of Michigan, Michigan MedicineRecruiting
  • Helen DeVos Children's Hospital
  • SSM Health Cardinal Glennon Children's Hospital
  • Washington University School of MedicineRecruiting
  • Billings ClinicRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • Morristown Medical Center
  • Rutgers - Robert Wood Johnson Medical SchoolRecruiting
  • Lenox Hill Hospital Cystic Fibrosis CenterRecruiting
  • Children's Hospital of New York
  • New York Medical College at Westchester Medical CenterRecruiting
  • Children's Hospital Medical Center of AkronRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • University of Cincinnati Medical Center
  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical CenterRecruiting
  • Nationwide Children's HospitalRecruiting
  • Dayton Children's HospitalRecruiting
  • Toledo Children's HospitalRecruiting
  • Oklahoma Cystic Fibrosis CenterRecruiting
  • Oregon Health Sciences UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Children's Hospital of Pittsburgh of UPMCRecruiting
  • Medical University of South CarolinaRecruiting
  • Vanderbilt Children's Hospital
  • University of Texas Southwestern / Children's HealthRecruiting
  • University of Texas SouthwesternRecruiting
  • Cook Children's Medical CenterRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Seattle Children's HospitalRecruiting
  • University of Washington Medical CenterRecruiting
  • Providence Medical Group, Cystic Fibrosis ClinicRecruiting
  • West Virginia University - Morgantown
  • University of Wisconsin
  • University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)Recruiting
  • CF Centre Hospital for Sick Children (Toronto, ON)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

β-lactam Only (Non-AG)

β-lactam and Aminoglycoside (AG)

Arm Description

Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam as selected by their treating physician. Treatment must not include an IV aminoglycoside.

Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician.

Outcomes

Primary Outcome Measures

Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)
Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).

Secondary Outcome Measures

Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days). The CFRSD-CRISS is derived from a set of questions asking a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.

Full Information

First Posted
September 16, 2022
Last Updated
September 8, 2023
Sponsor
Chris Goss
Collaborators
University of Washington, Medical University of South Carolina, Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05548283
Brief Title
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
Acronym
STOP360AG
Official Title
Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2023 (Actual)
Primary Completion Date
November 15, 2026 (Anticipated)
Study Completion Date
November 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chris Goss
Collaborators
University of Washington, Medical University of South Carolina, Cystic Fibrosis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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?
Detailed Description
Cystic Fibrosis Foundation (CFF) treatment guidelines for the management of pulmonary exacerbations (PEx) identified evidence gaps in current clinical best practices. The STOP program offers a platform for the conduct of controlled trials to develop the evidence base in order to define clinical best practices. The interventional Aminoglycoside Study (AG Study) will be a prospective, multi-center, parallel group, randomized (1:1 ratio), open-label, superiority study of intravenous aminoglycoside and β-lactams versus intravenous β-lactams only. Randomization will occur at Visit 1. The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF PEx during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Keywords
Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The aminoglycoside study will compare treatment of an IV β-lactam and aminoglycoside (AG) versus an IV β-lactam only (non-AG). Individuals will be randomly assigned in a 1:1 fashion to receive either the AG or non-AG intervention for a planned 14 day course of IV antibiotics. IV antibiotic treatments for each intervention arm will be selected by the treating physician following standard of care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
730 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
β-lactam Only (Non-AG)
Arm Type
Other
Arm Description
Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam as selected by their treating physician. Treatment must not include an IV aminoglycoside.
Arm Title
β-lactam and Aminoglycoside (AG)
Arm Type
Other
Arm Description
Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician.
Intervention Type
Drug
Intervention Name(s)
Beta-lactam antibiotic
Other Intervention Name(s)
β-lactam
Intervention Description
Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
Intervention Type
Drug
Intervention Name(s)
Aminoglycoside
Other Intervention Name(s)
AG
Intervention Description
Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
Primary Outcome Measure Information:
Title
Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study
Description
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)
Time Frame
Four weeks
Title
Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms
Description
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).
Time Frame
Six Weeks
Secondary Outcome Measure Information:
Title
Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study
Description
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days). The CFRSD-CRISS is derived from a set of questions asking a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All genders ≥ 6 years of age at Visit 1 Documentation of a CF diagnosis Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials At least one documented Pa positive culture within two years prior to Visit 1 Exclusion Criteria: Participant is not pregnant No known renal impairment or history of solid organ transplantation No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1 No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1 No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachael Buckingham, BS
Phone
206-884-7517
Email
Rachael.buckingham@seattlechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Barbra Fogarty
Phone
206-884-7592
Email
Barbra.fogarty@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Flume, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital Alabama, University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Hathorne
Email
hyhathorne@uabmc.edu
Facility Name
Tucson Cystic Fibrosis Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Ryan
Email
elizabethryan@email.arizona.edu
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Querido
Email
glquerido@health.ucsd.edu
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marylee Melendrez
Email
mmelendrez@memorialcare.org
Facility Name
CHOC Children's Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Rodriguez
Email
eric.rodriguez@choc.org
Facility Name
University of California at Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Diaz-Vigil
Email
ddiazvigil@ucdavis.edu
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Serio
Email
jserio@childrensnational.org
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Lingis
Email
melissa.lingis@peds.ufl.edu
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris Alaby
Email
dalaby@mhs.net
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer (Jenn) Gafford
Email
Jennifer.gafford@nemours.org
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ylber Whitaker
Email
yiw2@miami.edu
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Hodge
Email
dhodge6@jhmi.edu
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashleigh Streby
Email
ashleigh.streby@emory.edu
Facility Name
Saint Luke's Cystic Fibrosis Center of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lejla Godusevic
Email
godusevl@slhs.org
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung Hsuan (Irene) Wu
Email
yhwu@luriechildrens.org
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Nelson
Email
rachel.nelson@northwestern.edu
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Scott
Email
Ashley.Scott@osfhealthcare.org
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Bendy
Email
lbendy@iu.edu
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Bendy
Email
lbendy@iupui.edu
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Teresi
Email
mary-teresi@uiowa.edu
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Scott
Email
lscott2@kumc.edu
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Thomas
Email
mcthom12@louisville.edu
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harmony Renna
Email
rennah@mmc.org
Facility Name
John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Pinto
Email
jpinto4@jh.edu
Facility Name
Boston Children's Hospital, Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Fowler
Email
Robert.fowler@childrens.harvard.edu
Facility Name
University of Massachusetts Memorial Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaclyn Longtine
Email
Jaclyn.Longtine@umassmed.edu
Facility Name
University of Michigan, Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Kruse
Email
dmkruse@med.umich.edu
Facility Name
Helen DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew James
Email
andrew.james@spectrumhealth.org
Facility Name
SSM Health Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freda Branch
Email
freda.branch@health.slu.edu
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irma Bauer
Email
irmabauer@wustl.edu
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerimiah Lysinger
Email
JLysinger@billingsclinic.org
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara A Rodgers
Email
Barbara.A.Rodgers@hitchcock.org
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Connolly
Email
Debra.Connolly@atlantichealth.org
Facility Name
Rutgers - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah McCloskey
Email
mcclosda@rwjms.rutgers.edu
Facility Name
Lenox Hill Hospital Cystic Fibrosis Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Demarco
Email
Tdemarco3@northwell.edu
Facility Name
Children's Hospital of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossein Sadeghi
Email
HS762@cumc.Columbia.edu
Facility Name
New York Medical College at Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Messer
Email
Zachary_Messer@nymc.edu
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Parrish
Email
MParrish@akronchildrens.org
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Thornton
Email
Kelly.Thornton@cchmc.org
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Hummel
Email
Nicole.Hummel@UCHealth.com
Facility Name
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Primary RC & Participant Contact General Contact
Email
RainbowCFResearch@UHhospitals.org
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Gilmore
Email
Diana.Gilmore@nationwidechildrens.org
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Jones
Email
Jonesa11@childrensdayton.org
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Hoot
Email
kelly.hoot@promedica.org
Facility Name
Oklahoma Cystic Fibrosis Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CF Center Participant Contact
Email
cfresearchteam@ouhsc.edu
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenna Bucher
Email
bucherj@ohsu.edu
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Molter
Email
melissa.molter@pennmedicine.upenn.edu
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hartigan
Email
elizabeth.hartigan@chp.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Warden
Email
jonesash@musc.edu
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brijesh Patel
Email
brijesh.patel@vumc.org
Facility Name
University of Texas Southwestern / Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Klosterman
Email
Mary.Klosterman@UTSouthwestern.edu
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Keller
Email
Ashley.Keller@UTSouthwestern.edu
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Finto
Email
jill.finto@cookchildrens.org
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akilah Pierre-Louis
Email
akilah.pierrelouis1@vcuhealth.org
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon McNamara
Email
sharon.mcnamara@seattlechildrens.org
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Gambol
Email
TGambol@medicine.washington.edu
Facility Name
Providence Medical Group, Cystic Fibrosis Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Milton
Email
joan.milton@providence.org
Facility Name
West Virginia University - Morgantown
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26507
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Clark
Email
tclark@hsc.wvu.edu
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Nelson
Email
mnelson@pediatrics.wisc.edu
Facility Name
University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Smith
Email
Clare.smith@albertahealthservices.ca
Facility Name
CF Centre Hospital for Sick Children (Toronto, ON)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Jeanneret-Manning

12. IPD Sharing Statement

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Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

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