Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial (STOP PEDS RCT)
University of Washington, the Collaborative Health Studies Coordinating Center
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.
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 t…
Eligibility
- Age range
- 3–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 1. For main cohort and non-HEMT cohort: age 6 to \<19 years 2. For preschool cohort: age 3 to \<6 years 2. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: 1. sweat chloride ≥ 60 mEq/liter 2. two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene 3. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with…
Interventions
- OtherImmediate Oral Antibiotics
Increase airway clearance and start 14 days of preselected oral antibiotics right away
- OtherTailored Treatment: Oral Antibiotics only if Additional Treatment needed
Increase airway clearance and start preselected oral antibiotics later if symptoms get worse or do not get better according to prespecified criteria
Locations (33)
- The Children's Hospital Alabama & University of Alabama at BirminghamBirmingham, Alabama
- Tucson Cystic Fibrosis CenterTucson, Arizona
- Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis ClinicLos Angeles, California
- Stanford UniversityPalo Alto, California
- Rady Children's Hospital at University of California San DiegoSan Diego, California
- Children's Hospital of ColoradoAurora, Colorado