Streamlined Treatment of Pulmonary Exacerbations in Pediatrics

Status Completed

Clinical Trial Summary

Clinical Trial Description

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. The primary endpoint is the proportion of participants in the tailored arm who did not take any oral antibiotics in the 28 days following randomization. Ultimately, we want to learn: - What is the best way to treat pulmonary exacerbations? - Should everyone with a pulmonary exacerbation take antibiotics? - Do the benefits of starting antibiotics at the first signs of illness outweigh the possible risks, like side effects and antibiotic resistance? This pilot study is designed to determine if an interventional study to help answer these questions is feasible. Up to 120 participants will be enrolled and followed through their well state of health, then for 28 days following their first randomized exacerbation. Enrollment will stop after 80 pulmonary exacerbation events have been randomized, even if this does not require 120 participants. Due to the nature of the study, the identity of treatment assignment will be known to investigators, research staff, and patients (ie, not blinded). Total duration of this pilot study is expected to be approximately 18 months: 6 months for participant recruitment and 12 months for follow up. Participants could be monitored for up to 18 months if they do not have an exacerbation. However, it is anticipated that the majority of participants will experience a randomizable PEx event and therefore have a shorter follow up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04608019
Study type	Interventional
Source	University of Washington, the Collaborative Health Studies Coordinating Center
Contact
Status	Completed
Phase	N/A
Start date	November 10, 2020
Completion date	August 18, 2022

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Streamlined Treatment of Pulmonary Exacerbations in Pediatrics — STOP-PEDS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms