Not a traditional drug phase: Immediate Oral Antibiotics for Cystic Fibrosis
The STOP PEDS RCT is a multicenter, parallel, open label randomly assigned controlled trial evaluating the long-term (one year) and short-term safety and how well it works of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.
Official registry: https://clinicaltrials.gov/study/NCT06654752 · University of Washington, the Collaborative Health Studies Coordinating Center · enrollment listed as 430
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Immediate Oral Antibiotics, or Tailored Treatment: Oral Antibiotics only if Additional Treatment needed. The registry lists allocation as randomized. The STOP PEDS RCT is a multicenter, parallel, open label randomly assigned controlled trial evaluating the long-term (one year) and short-term safety and how well it works of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.
They plan to enroll about 430 people at 33 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial (STOP PEDS RCT)
Interventions: Immediate Oral Antibiotics, Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Primary outcome (registry wording): One-year change in pulmonary function by spirometry-measured ppFEV1
Who it is for (from inclusion criteria)
- Ages 3 Years to 18 Years
- For main cohort and non-HEMT cohort: age 6 to \<19 years
- For preschool cohort: age 3 to \<6 years
- Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- sweat chloride ≥ 60 mEq/liter
- two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
- Highly Effective Modulator Therapy
- For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment
Who the registry excludes
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
- Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
- Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
- History of solid organ transplant
- History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
- Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
- Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
Public study contact (from the registry)
Erika Enright
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
33 listed- The Children's Hospital Alabama & University of Alabama at Birmingham — Birmingham, Alabama (recruiting)
- Tucson Cystic Fibrosis Center — Tucson, Arizona (recruiting)
- Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic — Los Angeles, California (recruiting)
- Stanford University — Palo Alto, California (recruiting)
- Rady Children's Hospital at University of California San Diego — San Diego, California (not_yet_recruiting)
- Children's Hospital of Colorado — Aurora, Colorado (recruiting)
- Children's Healthcare of Atlanta & Emory University — Atlanta, Georgia (recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University — Chicago, Illinois (recruiting)
- Riley Hospital for Children & Indiana University — Indianapolis, Indiana (recruiting)
- University of Iowa — Iowa City, Iowa (recruiting)
- Johns Hopkins Hospital, Johns Hopkins University — Baltimore, Maryland (recruiting)
- Boston Children's Hospital & Harvard University — Boston, Massachusetts (recruiting)
+ 2 sites outside the US on the same record
FAQ about this NCT record
Is NCT06654752 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06654752?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06654752?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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