Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608019
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-10-23
Brief Title:
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Pilot Study
Sponsor:
University of Washington the Collaborative Health Studies Coordinating Center
Organization:
University of Washington the Collaborative Health Studies Coordinating Center
Study Overview
Official Title:
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Pilot
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP-PEDS
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None