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Anti-Infective Closed to Enrollment
STOP-PEDS Pilot: Study to evaluate treatment of pulmonary exacerbations in children 6-18 years old with CF (STOP-PEDS Pilot)
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.
Eligibility
-
Age:
6 Years to 18 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Design
-
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
-
Phase: ?more info
Phase Four/Post-Approval -
Study Sponsor: ?more info
Sanders, Don -
Study Drugs:
N/A
Study Sites
-
Closed to Enrollment
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
-
Closed to Enrollment
Colorado
Children's Hospital Colorado, Aurora, CO 80045
-
Closed to Enrollment
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30322
-
Closed to Enrollment
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
-
Closed to Enrollment
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
-
Closed to Enrollment
Michigan
Corewell Health Helen DeVos, Grand Rapids , MI 49503
-
Closed to Enrollment
Oregon
Oregon Health & Science University, Portland, OR 97239
-
Closed to Enrollment
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
-
Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
-
Closed to Enrollment
Washington
Seattle Children's Hospital, Seattle, WA 98105
Eligibility
-
Age:
6 Years to 18 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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