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Streamlined Treatment of Pulmonary Exacerbations in Pediatrics

NCT06654752 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2026-05-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Immediate Oral Antibiotics

Increase airway clearance and start 14 days of preselected oral antibiotics right away

OTHER

Tailored Treatment: Oral Antibiotics only if Additional Treatment needed

Increase airway clearance and start preselected oral antibiotics later if symptoms get worse or do not get better according to prespecified criteria

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of Washington, the Collaborative Health Studies Coordinating Center

    lead OTHER

Principal Investigators

  • D. B. Sanders, MD, MS · Indiana University

  • Margaret Rosenfeld, MD, MPH · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2027-12-30
Completion
2029-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654752 on ClinicalTrials.gov