STOP PEDS RCT (Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial)
In this study, we are going to compare two ways of treating mild respiratory illnesses in children with Cystic Fibrosis (CF). One is immediate antibiotics (increase airway clearance and start oral antibiotics right away) and the other is tailored therapy (increase airway clearance right away but only start oral antibiotics if symptoms worsen or do not improve). We are looking at how safe each option is and how well each one works. To do this, we will randomize participants (like flipping a coin) to one of these two approaches if a mild respiratory illness happens over the next 12 months.
• Age: for main study group and non-HEMT group: age 6 to less than 19 years old OR for preschool group: age 3 to less than 6 years old
• diagnosis of Cystic Fibrosis (CF)
• for main study group and non-highly effective modulator therapy (HEMT) group, able to do spirometry
• able to receive text messages and access the internet
• see link to clincialtrials.gov for complete inclusion criteria
• history of solid organ transplant
• positive culture for Mycobacterium abscessus in the prior 12 months
• three or more IV antibiotic-treated pulmonary exacerbations (PEx) in the prior 12 months
• treatment with chronic oral antibiotics other than azithromycin at enrollment
• see link to clinicaltrials.gov for complete exclusion criteria
Other: Immediate Oral Antibiotics, Other: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Children's Health, Respiratory System
CF, Cystic fibrosis