Page Title
Clinical Trial Finder
Anti-Infective Enrolling
Study to evaluate the standardizing of treatment for pulmonary exacerbations in children and adults with CF ages 6 and older. (STOP360-IP-22)
This study will look at pulmonary exacerbations, which are a worsening of respiratory symptoms, in people with CF who need to be treated with intravenous (IV) antibiotics. It will compare treatment with one antibiotic (a beta-lactam) to treatment with two antibiotics (tobramycin and a beta-lactam) to learn whether there is a difference in lung function and symptom improvement between the two groups. This study is for people ages 6 and older.
This study is part of the STOP program platform, which has been developed to conduct trials that help evaluate the best way to treat pulmonary exacerbations in people with CF. In this study, participants will be randomized with half receiving treatment with one antibiotic (a beta-lactam) and half receiving treatment with two antibiotics (tobramycin and a beta-lactam). The specific IV antibiotic treatment will be selected by the treating physician as part of a patient’s usual care. This study is open label, so all participants will receive antibiotics and will know which antibiotics they are receiving.
This study is for patients whose clinician plans to treat them with a 14-day course of IV antibiotics and who have had at least one Pseudomonas-positive sputum or throat culture in the past two years.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have had at least one documented Pseudomonas aeruginosa positive culture within two years prior to Visit 1.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
48 days -
Number of Study Visits:
3
Additional Information
-
Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Goss, Christopher -
Study Drugs:
N/A
Study Sites
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Enrolling
Alabama
The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233
Contact
Heather Hathorne
Phone: +1 (205) 638-9568
Email: hyhathorne@uabmc.edu
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Enrolling
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Elizabeth Ryan
Phone: +1 (520) 850-8688
Email: elizabethryan@arizona.edu
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Enrolling
California
CHOC Children's Hospital, Orange, CA 92868
Contact
Lila Klein
Phone: +1 (714) 509-4341
Email: Lila.klein@choc.org
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Enrolling
California
University of California at Davis Medical Center, Sacramento, CA 95817
Contact
Daniel Diaz-Vigil
Phone: +1 (916) 734-8686
Email: ddiazvigil@ucdavis.edu
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Enrolling
California
University of California San Diego, La Jolla, CA 92037
Contact
Jenna Mielke
Phone: +1 (619) 471-0822
Email: jmielke@health.ucsd.edu
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Enrolling
California
Long Beach Memorial Medical Center, Long Beach, CA 90806
Contact
Marylee Melendrez
Phone: +1 (562) 933-1851
Email: mmelendrez@memorialcare.org
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Enrolling
District of Columbia
Children's National Medical Center, Washington, DC 20010
Contact
Iman Sami
Phone: +1 (202) 476-3519
Email: isami@cnmc.org
-
Enrolling
Florida
University of Florida, Gainesville, FL 32610
Contact
Melissa Lingis
Phone: +1 (352) 294-8556
Email: melissa.lingis@peds.ufl.edu
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Enrolling
Florida
All Children's Hospital, St. Petersburg, FL 33701
Contact
Diana Hodge
Phone: +1 (727) 767-6881
Email: dhodge6@jhmi.edu
-
Enrolling
Florida
University of Miami, Miami, FL 33136
Contact
Ylber (Ivan) Whitaker
Phone: +1 (305) 243-5545
Email: yiw2@miami.edu
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Enrolling
Florida
Joe DiMaggio Children's Hospital, Hollywood, FL 33021
Contact
Norma (Jean) Barton
Phone: +1 (954) 265-4466
Email: nbarton@mhs.net
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Enrolling
Florida
Nemours Children's Clinic - Jacksonville, Jacksonville, FL 32207
Contact
Jennifer (Jenn) Gafford
Phone: +1 (904) 697-3600
Email: Jennifer.gafford@nemours.org
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Enrolling
Georgia
Emory University, Atlanta, GA 30324
Contact
Ashleigh Streby
Phone: +1 (404) 727-0305
Email: ashleigh.streby@emory.edu
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Enrolling
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
Contact
Lejla Godusevic
Phone: +1 (208) 381-4717
Email: godusevl@slhs.org
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Enrolling
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
Contact
Tina Carter
Phone: +1
Email: tmcarter@luriechildrens.org
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Enrolling
Illinois
OSF Saint Francis Medical Center, Peoria, IL 61637
Contact
Ashley Scott
Phone: +1 (309) 624-2409
Email: Ashley.Scott@osfhealthcare.org
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Enrolling
Illinois
Northwestern University, Chicago, IL 60611
Contact
Rachel Nelson
Phone: +1 (312) 695-0415
Email: rachel.nelson@northwestern.edu
-
Enrolling
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling
Iowa
University of Iowa, Iowa City, IA 52242
Contact
Mary Teresi
Phone: +1 (319) 384-7546
Email: mary-teresi@uiowa.edu
-
Enrolling
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling
Kentucky
University of Louisville, Louisville, KY 40202
Contact
Melissa Thomas
Phone: +1
Email: mcthom12@louisville.edu
-
Enrolling
Maine
Maine Medical Center, Portland, ME 04102
Contact
Harmony Renna
Phone: +1 (207) 662-5917
Email: Harmony.Renna@mainehealth.org
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Enrolling
Maryland
Johns Hopkins University, Baltimore, MD 21205
Contact
Jeanne Pinto
Phone: +1 (410) 955-9782
Email: jpinto4@jh.edu
-
Enrolling
Massachusetts
University of Massachusetts Memorial Health Care, Worcester, MA 01655
Contact
Jaclyn Longtine
Phone: +1 (508) 856-5472
Email: Jaclyn.Longtine@umassmed.edu
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Enrolling
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
-
Enrolling
Michigan
Corewell Health Helen DeVos, Grand Rapids , MI 49503
Contact
Andrew James
Phone: +1 (616) 267-0870
Email: andrew.james@corewellhealth.org
-
Enrolling
Missouri
SSM Health Cardinal Glennon Children’s Hospital, St. Louis, MO 63104
Contact
Freda Branch
Phone: +1 (314) 678-5468
Email: freda.branch@health.slu.edu
-
Enrolling
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling
Montana
Billings Clinic , Billings, MT 59101
Contact
Jerimiah Lysinger
Phone: +1 (406) 238-5137
Email: JLysinger@billingsclinic.org
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Enrolling
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
Contact
Barbara Rodgers
Phone: +1 (603) 650-9718
Email: Barbara.A.Rodgers@hitchcock.org
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Enrolling
New Jersey
Morristown Medical Center , Morristown, NJ 07960
Contact
Debra Connolly
Phone: +1 (973) 971-7293
Email: Debra.Connolly@atlantichealth.org
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Enrolling
New Jersey
Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ 08903
Contact
Sheila Redding
Phone: +1
Email: sr1238@rwjms.rutgers.edu
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Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
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Enrolling
New York
Children's Hospital of New York, New York, NY 10032
Contact
Hossein Sadeghi
Phone: +1 (212) 305-5122
Email: HS762@cumc.Columbia.edu
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Enrolling
New York
Lenox Hill Hospital Cystic Fibrosis Center, New York, NY 10028
Contact
Teresa Demarco
Phone: +1 (212) 434-4790
Email: Tdemarco3@northwell.edu
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Enrolling
Ohio
Dayton Children's Hospital, Dayton, OH 45404
Contact
Amy Jones
Phone: +1 (937) 641-3693
Email: Jonesa11@childrensdayton.org
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Enrolling
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
Contact
Kelly Thornton
Phone: +1 (513) 636-0604
Email: Kelly.Thornton@cchmc.org
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Enrolling
Ohio
Toledo Children's Hospital, Toledo, OH 43606
Contact
Kelly Hoot
Phone: +1 (419) 291-4630
Email: kelly.hoot@promedica.org
-
Enrolling
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
Contact
Nicole Hummel
Phone: +1 (513) 558-7036
Email: hummelne@ucmail.uc.edu
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Enrolling
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
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Enrolling
Ohio
Children's Hospital Medical Center of Akron, Akron, OH 44308
Contact
Michelle Parrish
Phone: +1 (330) 543-3089
Email: MParrish@akronchildrens.org
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Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
Contact
Participant Contact Oklahoma Cystic Fibrosis Center
Phone: +1 (405) 271-6216
Email: cfresearchteam@ouhsc.edu
-
Enrolling
Oregon
Oregon Health & Science University, Portland, OR 97239
Contact
Jenna Bucher
Phone: +1 (503) 494-7807
Email: bucherj@ohsu.edu
-
Enrolling
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
-
Enrolling
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
-
Enrolling
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
-
Enrolling
Tennessee
Vanderbilt Children's Hospital, Nashville, TN 37232
Contact
Brijesh Patel
Phone: +1 (615) 343-4865
Email: brijesh.patel@vumc.org
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Enrolling
Texas
University of Texas Southwestern / Children’s Health, Dallas, TX 75207
Contact
Keianna Brown
Phone: +1 (214) 456-5489
Email: Keianna.brown@utsouthwestern.edu
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Enrolling
Texas
Cook Children's Medical Center, Fort Worth, TX 76104
Contact
Anna Reyes
Phone: +1 (682) 885-6589
Email: anna.reyes@cookchildrens.org
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Enrolling
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-6233
Email: Ashley.Keller@UTSouthwestern.edu
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Enrolling
Virginia
Virginia Commonwealth University, Richmond, VA 23219
Contact
Akilah Pierre-Louis
Phone: +1
Email: akilah.pierrelouis1@vcuhealth.org
-
Enrolling
Washington
Seattle Children's Hospital, Seattle, WA 98105
Contact
Sharon McNamara
Phone: +1 (206) 987-3921
Email: sharon.mcnamara@seattlechildrens.org
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Enrolling
Washington
Providence Medical Group, Cystic Fibrosis Clinic, Spokane, WA 99204
Contact
Joan Milton
Phone: +1 (509) 474-4323
Email: joan.milton@providence.org
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Enrolling
Washington
University of Washington Medical Center, Seattle, WA 98195
Contact
Lauren Bartlett
Phone: +1 (503) 583-2869
Email: lrejman@uw.edu
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Enrolling
West Virginia
West Virginia University - Morgantown, Morgantown, WV 26507
Contact
Tammy Clark
Phone: +1 (304) 293-5264
Email: tclark@hsc.wvu.edu
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Enrolling
Wisconsin
University of Wisconsin, Madison, WI 53792
Contact
Melanie Nelson
Phone: +1 (608) 265-4617
Email: mnelson@pediatrics.wisc.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit -
Pseudomonas Status:
Positive Respiratory Cultures Required
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have had at least one documented Pseudomonas aeruginosa positive culture within two years prior to Visit 1.
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