Streamlined Treatment of Pulmonary Exacerbations in Pediatrics

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: University of Washington, the Collaborative Health Studies Coordinating Center
Study ID: NCT06654752
Status: Recruiting

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Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: ALL
Age: 3 Years - 18 Years
Healthy Volunteers: Not accepted

Interventions

Immediate Oral Antibiotics — OTHER
Increase airway clearance and start 14 days of preselected oral antibiotics right away
Tailored Treatment: Oral Antibiotics only if Additional Treatment needed — OTHER
Increase airway clearance and start preselected oral antibiotics later if symptoms get worse or do not get better according to prespecified criteria

Study Details

The STOP PEDS RCT is a multicenter, parallel, open label randomized controlled trial evaluating the long-term (one year) and short-term safety and efficacy of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.

Key Dates

Start date: Dec 1, 2024
Status verified: May 2026
Primary completion: Dec 30, 2027
Completion: Feb 28, 2029

Study Design

Enrollment: 430 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Immediate Antibiotics
Increased airway clearance plus early initiation of oral antibiotics
Experimental: Tailored Therapy
Increased airway clearance alone, with addition of oral antibiotics for worsening symptoms or failure to improve

Primary Outcome Measure

One-year change in pulmonary function by spirometry-measured ppFEV1 [ Time Frame: 1 year ]

Central Contacts

Erika Enright
206-897-1922
[email protected]

Locations (31)

Facility	City	State	ZIP	Site coordinators
The Children's Hospital Alabama & University of Alabama at Birmingham	Birmingham	Alabama	35233	Ashlyn Hastings [email protected] Christopher Fowler, MD (PRINCIPAL_INVESTIGATOR)
Tucson Cystic Fibrosis Center	Tucson	Arizona	85713	Elizabeth (Lisa) Ryan [email protected] Cori Daines, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic	Los Angeles	California	90027	Jared Lopez, BA [email protected] Martha McKinney, MD (PRINCIPAL_INVESTIGATOR)
Stanford University	Palo Alto	California	94304	Tina Conti, BSRC, RRT, RRT-NPS, C-NPT [email protected] Lori WaiHang Lee, MD (PRINCIPAL_INVESTIGATOR)
Rady Children's Hospital at University of California San Diego	San Diego	California	92123	Lisa Ramos, CRC [email protected] Kathryn Akong, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Colorado	Aurora	Colorado	80045	Mary Cross [email protected] Jordana Hoppe, MD (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of Atlanta & Emory University	Atlanta	Georgia	30322	Joy Dangerfield [email protected] Ajay Kasi, MD (PRINCIPAL_INVESTIGATOR)
Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University	Chicago	Illinois	60611	Mariah Flowers [email protected] Maria Dowell, MD (PRINCIPAL_INVESTIGATOR)
Riley Hospital for Children & Indiana University	Indianapolis	Indiana	46202	Misty Thompson [email protected] Lisa Bendy [email protected] D. B. Sanders, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Iowa	Iowa City	Iowa	52242	Mary Teresi [email protected] Anthony Fischer, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Hospital, Johns Hopkins University	Baltimore	Maryland	21287	Jamelia Maynard [email protected] Peter Mogayzel, MD, PhD, MBA (PRINCIPAL_INVESTIGATOR)
Boston Children's Hospital & Harvard University	Boston	Massachusetts	02115	Monica Ulles [email protected] Gregory Sawicki, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health System	Ann Arbor	Michigan	48109-5212	Dawn Kruse [email protected] Samya Nasr, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota	55404	Danniella Balangoy [email protected] Brooke Moore, MD (PRINCIPAL_INVESTIGATOR)
The Minnesota Cystic Fibrosis Center & University of Minnesota	Minneapolis	Minnesota	55455	Alyssa Perry [email protected] Samuel Goldfarb, MD (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospital	Kansas City	Missouri	64108	Jana Lomonte [email protected] Hugo Escobar, MD (PRINCIPAL_INVESTIGATOR)
St. Louis Children's Hospital & Washington University School of Medicine	St Louis	Missouri	63110	Emily Schulte, RN, BSN [email protected] Jessica Pittman, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical Center Strong Memorial	Rochester	New York	14642	Barbara Johnson, RN [email protected] Karen McCarthy [email protected] Matthew McGraw, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27514	Caroline Flowers, CRC [email protected] Jennifer Goralski, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Sharon Kadon, RN, BSN, CPN [email protected] Gary McPhail, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science University	Portland	Oregon	97239-3098	Pierce Nusbaum [email protected] Kelvin MacDonald, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Philadelphia & University of Pennsylvania	Philadelphia	Pennsylvania	19104	Matthew Gari [email protected] Erin Donnelly [email protected] Clement Ren, MD, MBA (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15224	Adrienne DeRicco, RN [email protected] Daniel Weiner, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina	Charleston	South Carolina	29425	Audra Wiser [email protected] Sylvia E Szentpeter, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern & Children's Health	Dallas	Texas	75235	Lindsay Allen, CRC [email protected] Preeti Sharma, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's Hospital & Baylor College of Medicine	Houston	Texas	77030	Pavel Tuekam [email protected] Fadel Ruiz, MD (PRINCIPAL_INVESTIGATOR)
Vermont Children's Hospital & University of Vermont Medical Center	Burlington	Vermont	05401	Vanessa Marascio [email protected] Thomas Lahiri, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University	Richmond	Virginia	23298	Akilah Pierre-Louis, CRC [email protected] Andrew T. Barber, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's Hospital	Seattle	Washington	98105	Mey Lee [email protected] Margaret Rosenfeld, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin	Madison	Wisconsin	53792	Nikki Cole, BS, RRT, CCRC [email protected] Hara Levy, MD (PRINCIPAL_INVESTIGATOR)
Children's Wisconsin & Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Laura Roth, CCRC [email protected] Nicholas Antos, MD (PRINCIPAL_INVESTIGATOR)

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