Comparing Immediate with Tailored Treatment: for cystic fibrosis
Official title: Streamlined Treatment of Pulmonary Exacerbations in Pediatrics
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial (STOP PEDS RCT)
- 2 groups
- Sites in Vancouver and Toronto
- Recruiting
Interventions
- Other intervention
Immediate Oral Antibiotics
Increase airway clearance and start 14 days of preselected oral antibiotics right away
- Other intervention
Tailored 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
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia
- Recruiting
The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics
Toronto, Ontario
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +For main cohortCohortA group of participants sharing a characteristic, followed together.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +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 lumacaftor-ivacaftor for at least 3 months
- +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
Exclusion
- −Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −Presence of a condition or abnormality that in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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-screenedScreeningThe checks done before joining, to see whether a study fits.Read more → ≥21 days after completion of antibiotics if they are at their baselineBaselineYour starting measurements, taken before treatment begins.Read more → state of health, per self-report
- −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 baseline, per self-report
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Immediate Oral Antibiotics.
Registry label: A: Immediate Antibiotics
Group B receives Tailored Treatment: Oral Antibiotics only if Additional Treatment needed.
Registry label: B: Tailored Therapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 3 years to 18 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 430 people.
The study is currently expected to finish around February 2029.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
One-year change in pulmonary function by spirometry-measured ppFEV1 — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06654752 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Immediate Oral AntibioticsOther
Increase airway clearance and start 14 days of preselected oral antibiotics right away
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Tailored Treatment: Oral Antibiotics only if Additional Treatment neededOther
Increase airway clearance and start preselected oral antibiotics later if symptoms get worse or do not get better according to prespecified criteria
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 3 years to 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 3 years to 18 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2029-02-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 430 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Ann Arbor, Michigan, United States; Minneapolis, Minnesota, United States; Rochester, New York, United States; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (5)
University of Michigan Health System
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
The Minnesota Cystic Fibrosis Center & University of Minnesota
Minneapolis, Minnesota, United States
University of Rochester Medical Center Strong Memorial
Rochester, New York, United States
Seattle Children's Hospital
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.