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Anti-biotics

Antibiotic Treatments for Cystic Fibrosis (STOP PEDS RCT Trial)

N/A
Waitlist Available
Led By Margaret Rosenfeld, MD, MPH
Research Sponsored by University of Washington, the Collaborative Health Studies Coordinating Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to perform acceptable and reproducible spirometry
Age 6 to <19 years for main cohort and non-HEMT cohort, age 3 to <6 years for preschool cohort
Must not have
History of solid organ transplant
Treatment with antibiotics for NTM at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two different antibiotic treatments for children with cystic fibrosis who have lung infections. They want to see which treatment is safer and more effective in the short-term and long-term.

Who is the study for?
This trial is for children and teens with Cystic Fibrosis who can give consent, use text messaging and the internet, perform spirometry tests, and meet specific health criteria. It's not for those recently on antibiotics or steroids, with certain infections or organ transplants, or on chronic oral antibiotics.
What is being tested?
The STOP PEDS RCT compares two antibiotic treatments for managing pulmonary exacerbations in kids with CF: one starts oral antibiotics only if needed later; the other begins immediate oral antibiotics. The study observes long-term (one year) and short-term safety and effectiveness.
What are the potential side effects?
While specific side effects are not listed here, generally speaking, antibiotic treatment may cause digestive issues like diarrhea or nausea, allergic reactions ranging from rashes to more severe responses depending on individual sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can successfully complete lung function tests.
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I am between 6 to 18 years old for the main study, or 3 to 5 for a specific subgroup.
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I have been diagnosed with cystic fibrosis based on symptoms and either a sweat test or genetic testing.
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My lung function is at least half of what is expected for someone my age and size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a solid organ transplant.
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I am currently being treated with antibiotics for NTM.
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I've had several lung infections treated with IV antibiotics in the last year.
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I am not taking any chronic oral antibiotics, except for azithromycin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
One-year change in pulmonary function by spirometry-measured ppFEV1
Secondary study objectives
One-Year change in pulmonary function by LCI
Other study objectives
Clinic Throat Swab Substudy 1: Metagenomic Sequencing
Clinic Throat Swab Substudy 2: Microbiota Measures
Health care costs 1: Total estimated cost of antibiotics
+48 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tailored TherapyExperimental Treatment1 Intervention
Increased airway clearance alone, with addition of oral antibiotics for worsening symptoms or failure to improve
Group II: Immediate AntibioticsExperimental Treatment1 Intervention
Increased airway clearance plus early initiation of oral antibiotics

Find a Location

Who is running the clinical trial?

University of Washington, the Collaborative Health Studies Coordinating CenterLead Sponsor
6 Previous Clinical Trials
9,625 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
737 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
196 Previous Clinical Trials
36,940 Total Patients Enrolled
189 Trials studying Cystic Fibrosis
34,043 Patients Enrolled for Cystic Fibrosis
Margaret Rosenfeld, MD, MPHPrincipal InvestigatorSeattle Children's Research Institute
7 Previous Clinical Trials
2,018 Total Patients Enrolled
6 Trials studying Cystic Fibrosis
1,970 Patients Enrolled for Cystic Fibrosis
~287 spots leftby Dec 2027
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