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Anti-Infective Enrolling
STOP-PEDS Pilot: Study to evaluate treatment of pulmonary exacerbations in children 6-18 years old with CF (STOP-PEDS 2.0)
This study will evaluate children 6 to 18 years old with CF to determine the acceptability and feasibility of a larger trial comparing immediate antibiotics versus tailored therapy for pulmonary exacerbation treatment.
This is a pilot study, meaning it is a preliminary small-scale study, taking place at multiple care centers across the U.S. It is designed to determine if a larger interventional study is feasible. Ultimately, researchers want to learn the best way to treat pulmonary exacerbations in pediatric and adolescent participants, determining whether everyone with an exacerbation should take antibiotics and whether the benefits of starting antibiotics at the first sign of illness outweigh the possible risks, such as side effects and antibiotic resistance.
This study is randomized and open label, meaning some participants will increase airway clearance and start oral antibiotics right after an exacerbation, and some will increase airway clearance and only start oral antibiotics later if symptoms get worse or do not get better. Researchers will follow participants for 28 days after their first exacerbation. They will measure the number of participants who did not take any oral antibiotics in the 28 days after an exacerbation. They will also measure the number of participants who consented to enroll in the study, the number of exacerbations, and the number of participants who attended a follow-up visit at day 28.
This study will require lung function tests and/or other measurements.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
18 months -
Number of Study Visits:
3
Additional Information
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Phase: ?more info
Phase Four/Post-Approval -
Study Sponsor: ?more info
Sanders, Don -
Study Drugs:
N/A
Study Sites
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Enrolling Soon
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Monica Varela
Phone: +1 (520) 626-0462
Email: monicavarela@email.arizona.edu
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Enrolling Soon
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Meg Anthony
Phone: +1 (720) 777-2945
Email: Meg.Anthony@childrenscolorado.org
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Enrolling Soon
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30322
Contact
Eric Hunter
Phone: +1 (404) 727-7398
Email: eahunte@emory.edu
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Enrolling Soon
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
Contact
Larissa Rugg
Phone: +1 (312) 227-6865
Email: lrugg@luriechildrens.org
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Enrolling
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
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Enrolling Soon
Michigan
Helen DeVos Children's Hospital, Grand Rapids , MI 49503
Contact
Cynthia Gile
Phone: +1 (616) 391-6148
Email: Cynthia.Gile@spectrumhealth.org
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Enrolling Soon
Oregon
Oregon Health Sciences University, Portland, OR 97239
Contact
Brendan Klein
Phone: +1 (503) 418-8108
Email: kleinb@ohsu.edu
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Enrolling Soon
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
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Enrolling Soon
Texas
Baylor College of Medicine, Houston, TX 77030
Contact
Katie Howe
Phone: +1 (832) 822-4252
Email: klhowe@texaschildrens.org
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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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