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New treatment option for Cystic Fibrosis
Official title Streamlined Treatment of Pulmonary Exacerbations in Pediatrics
ClinicalTrials.gov ID: NCT06654752
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- For main cohort and non-HEMT cohort: age 6 to \<19 years
- For preschool cohort: age 3 to \<6 years
- 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...
- sweat chloride ≥ 60 mEq/liter
- two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
You likely can't join if
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the...
- Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be...
- Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after...
- History of solid organ transplant
- History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
- Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
See the full eligibility criteria
- For main cohort and non-HEMT cohort: age 6 to \<19 years
- For preschool cohort: age 3 to \<6 years
- 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:
- sweat chloride ≥ 60 mEq/liter
- two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
- Highly Effective Modulator Therapy
- For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment
- For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or...
- For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
- For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
- Ability to receive text messages and access the internet
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
- Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their...
- Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical...
- History of solid organ transplant
- History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
- Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
- Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
- Treatment with chronic oral antibiotics other than azithromycin at enrollment
- Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Diego, California, United States; Aurora, Colorado, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.