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Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Pilot Study

NCT04608019 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2024-10-18

No results posted yet for this study

Summary

STOP PEDS is a pilot study of children with CF ages 6-18 across 10 sites in North America. The primary goal is to assess the acceptability and feasibility of a multicenter randomized trial comparing immediate antibiotics versus tailored therapy for pulmonary exacerbation (PEx) treatment in this population.

Conditions

Interventions

OTHER

Immediate Antibiotics

increase airway clearance/start oral antibiotics right away

OTHER

Tailored Treatment

increase airway clearance and start oral antibiotics later if symptoms get worse or do not get better

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of Washington, the Collaborative Health Studies Coordinating Center

    lead OTHER

Principal Investigators

  • Donald B. Sanders, MD · Riley Children's Hospital, Indianapolis, IN

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2022-08-18
Completion
2022-08-18

Countries

  • United States

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 NCT04608019 on ClinicalTrials.gov