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Comparing antibiotic treatments for lung issues in cystic fibrosis

Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)

Phase 4 Interventional Seattle Children's Hospital · NCT05548283

This study is testing whether a combination of two types of antibiotics can help people with cystic fibrosis recover better from lung problems than using just one type of antibiotic.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment730 (estimated)
Ages6 Years and up
SexAll
SponsorSeattle Children's Hospital Academic / other
Locations60 sites (Birmingham, Alabama and 59 other locations)
Trial IDNCT05548283 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of different antibiotic treatments for pulmonary exacerbations in patients with cystic fibrosis (CF). It aims to determine whether using a combination of aminoglycoside and beta-lactam antibiotics is more beneficial than using beta-lactams alone. The study will involve a randomized, open-label design with participants receiving either treatment for a planned 14-day course. The primary outcome will be measured by changes in lung function, specifically the Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1), from the start to the end of the treatment period.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 6 years and older with a confirmed diagnosis of cystic fibrosis experiencing a pulmonary exacerbation requiring intravenous antibiotic treatment.

Not a fit: Patients with renal impairment, a history of solid organ transplantation, or those who have recently received certain treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for pulmonary exacerbations in cystic fibrosis patients, enhancing their lung function and overall health.

How similar studies have performed: Previous studies have indicated the need for standardized treatment approaches in cystic fibrosis, suggesting that this study's focus on antibiotic comparison is both relevant and necessary.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* All genders ≥ 6 years of age at Visit 1
* Documentation of a CF diagnosis
* Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials
* At least one documented Pa positive culture within two years prior to Visit 1

Exclusion Criteria:

* Participant is not pregnant
* No known renal impairment or history of solid organ transplantation
* No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
* No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1
* No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
* No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1

Where this trial is running

Birmingham, Alabama and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cystic FibrosisCystic Fibrosis Pulmonary ExacerbationCFaminoglycosidebeta-lactamβ-lactamSTOPSTOP360
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.