Antibiotic Treatments for Cystic Fibrosis
(STOP PEDS RCT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two antibiotic approaches for children with cystic fibrosis (CF) experiencing lung flare-ups. The goal is to determine which method—starting antibiotics immediately (Immediate Oral Antibiotics) or using them only if symptoms worsen (Tailored Treatment: Oral Antibiotics only if Additional Treatment needed)—proves more effective and safer over a year. Children diagnosed with CF who can perform a simple lung test may qualify. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance treatment strategies for CF.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before enrolling. You cannot be on an acute course of oral or IV antibiotics or systemic corticosteroids within 14 days prior to enrollment, and you cannot be on chronic oral antibiotics other than azithromycin at enrollment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that taking oral antibiotics immediately for cystic fibrosis (CF) often works well and is easy for patients to manage. One study found that a single course of these antibiotics helps manage lung flare-ups in CF patients. Another study discovered that 70% of patients didn't need antibiotics, suggesting many people do well without them initially. This indicates that antibiotics are generally safe when used early, but not everyone needs them right away.
For a more personalized treatment approach, where antibiotics are given only if necessary, studies have also shown good results. Patients start with increased airway clearance and receive antibiotics only if their symptoms worsen or don't improve. This method has been tested for safety and is considered a reasonable option for managing CF. Overall, both strategies have proven safe for treating CF in children.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for cystic fibrosis because they offer a more personalized approach compared to traditional methods, which often rely on a fixed schedule of antibiotics. The Immediate Antibiotics treatment provides early intervention with oral antibiotics and increased airway clearance, potentially reducing the severity of infections right from the start. Meanwhile, the Tailored Therapy focuses on increased airway clearance alone, with antibiotics added only if symptoms worsen, allowing for a more adaptable and potentially less antibiotic-heavy regimen. This flexible approach could minimize antibiotic resistance and side effects, addressing a key concern with long-term antibiotic use.
What evidence suggests that this trial's treatments could be effective for cystic fibrosis?
This trial compares two approaches to antibiotic treatment for cystic fibrosis. Participants in one arm receive Immediate Oral Antibiotics, which involves increased airway clearance and early initiation of oral antibiotics. Studies have shown that oral antibiotics effectively treat worsening lung symptoms in people with cystic fibrosis, improving both symptom severity and quality of life.
In the other arm, participants follow a Tailored Therapy approach, which involves increased airway clearance alone, adding oral antibiotics only if symptoms worsen or fail to improve. Research suggests that this personalized treatment plan allows for a more tailored approach to managing symptoms. Overall, both immediate and tailored antibiotic treatments effectively manage cystic fibrosis symptoms.12367Who Is on the Research Team?
D. B. Sanders, MD, MS
Principal Investigator
Indiana University
Margaret Rosenfeld, MD, MPH
Principal Investigator
Seattle Children's Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either immediate antibiotics or tailored therapy for pulmonary exacerbations, with increased airway clearance.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pulmonary function and adverse events.
Optional Substudies
Participants may enroll in optional substudies for additional monitoring and data collection, such as throat swabs and remote monitoring.
What Are the Treatments Tested in This Trial?
Interventions
- Immediate Oral Antibiotics
- Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Immediate Oral Antibiotics is already approved in European Union, United States, Canada for the following indications:
- Pulmonary exacerbations in pediatric cystic fibrosis patients
- Pulmonary exacerbations in pediatric cystic fibrosis patients
- Pulmonary exacerbations in pediatric cystic fibrosis patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington, the Collaborative Health Studies Coordinating Center
Lead Sponsor
Cystic Fibrosis Foundation
Collaborator