Back to search results

Aminoglycoside Study for Cystic Fibrosis Pulmonary Exacerbations

This study is for people with cystic fibrosis (CF) who are experiencing a pulmonary exacerbation (a worsening of lung symptoms needing medical treatment). It aims to find the best way to treat these exacerbations with intravenous (IV) antibiotics. Researchers are comparing two treatment approaches: receiving only a beta-lactam antibiotic (like penicillin) or receiving both a beta-lactam antibiotic and an aminoglycoside antibiotic (like tobramycin). You may be able to join if you are at least 6 years old, have a CF diagnosis, and your doctor plans to treat your exacerbation with 14 days of IV antibiotics. The study will measure how much your lung function (FEV1 % Predicted) improves after four weeks and track any side effects for six weeks. The current recruitment status is unclear.

Study design
This is an interventional study where participants will be randomly assigned to one of two treatment groups. It plans to enroll 730 participants.
What's involved
Participants will receive 14 days of intravenous antibiotics. Lung function will be measured at four weeks, and side effects will be tracked for six weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for four weeks to assess lung function and for six weeks to track adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05548283

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Recruiting
PHASE4Ages 6+InterventionalTreatment
Chris Goss
~730 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Beta-lactam antibioticAminoglycoside

At a glance

Recruiting sites
59 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study
Measured over Four weeks
+1 more outcome measured

Conditions

Cystic Fibrosis
Cystic Fibrosis Pulmonary Exacerbation

Explore related trials

Cystic Fibrosis

Where it's being run

60 sites across 33 states
Ohio7
Florida5
California4
Illinois3
New York3
Texas3
Washington3
Indiana2

Study leadership

  • Patrick Flume, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Rachael Buckingham, BS
[email protected]
206-884-7517
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) StudyFour weeks

    Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)

  • Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention ArmsSix Weeks

    Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).