Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654752
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial STOP PEDS RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP PEDS RCT
Brief 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
Detailed Description:
The STOP PEDS pilot study demonstrated that a randomized trial of treatment strategies for mild pulmonary exacerbations PEx in children with CF was feasible and that assignment to a tailored therapy arm defined below may reduce antibiotic exposure
Based on the research priorities identified by CF families and clinicians and the results of the pilot study 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 PEx in the pediatric CF population The two treatment arms are immediate antibiotics and tailored therapy In both arms participants will be instructed to increase airway clearance at the onset of an eligible PEx In the immediate antibiotics arm they will also begin 14 days of oral antibiotics preselected by their primary CF providers while in the tailored therapy they will only begin antibiotics if prespecified criteria for worsening symptoms or failure to improve are met
The STOP PEDS study will enroll three cohorts In the main cohort children ages 6-18 on highly effective modulator therapy HEMT will be enrolled when well and followed for 12 months Participants will be randomly assigned to a treatment arm and maintain that treatment assignment for all subsequent eligible PEx during their 12-month enrollment period Two additional pilot cohorts the preschool cohort children ages 3 to 5 on HEMT and the non-HEMT cohort children ages 6-18 not eligible for HEMT will be enrolled in parallel pilot studies Participants will enroll when well and be followed through one randomized PEx
Participants in the STOP PEDS RCT at selected sites will have the opportunity to enroll in optional substudies if eligible These substudies include
Clinic throat swab substudy
Home throat and nasal swab substudy
Remote monitoring substudy Home monitoring of lung function vital signs activity and sleep
Based on the research priorities identified by CF families and clinicians and the results of the pilot study 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 PEx in the pediatric CF population The two treatment arms are immediate antibiotics and tailored therapy In both arms participants will be instructed to increase airway clearance at the onset of an eligible PEx In the immediate antibiotics arm they will also begin 14 days of oral antibiotics preselected by their primary CF providers while in the tailored therapy they will only begin antibiotics if prespecified criteria for worsening symptoms or failure to improve are met
The STOP PEDS study will enroll three cohorts In the main cohort children ages 6-18 on highly effective modulator therapy HEMT will be enrolled when well and followed for 12 months Participants will be randomly assigned to a treatment arm and maintain that treatment assignment for all subsequent eligible PEx during their 12-month enrollment period Two additional pilot cohorts the preschool cohort children ages 3 to 5 on HEMT and the non-HEMT cohort children ages 6-18 not eligible for HEMT will be enrolled in parallel pilot studies Participants will enroll when well and be followed through one randomized PEx
Participants in the STOP PEDS RCT at selected sites will have the opportunity to enroll in optional substudies if eligible These substudies include
Clinic throat swab substudy
Home throat and nasal swab substudy
Remote monitoring substudy Home monitoring of lung function vital signs activity and sleep
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None