Comparing antibiotic treatments for lung issues in cystic fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Children's Hospital Alabama, University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Tucson Cystic Fibrosis Center
  Tucson, Arizona, United States Recruiting
• University of California San Diego
  La Jolla, California, United States Recruiting
• Long Beach Memorial Medical Center
  Long Beach, California, United States Recruiting
• CHOC Children's Hospital
  Orange, California, United States Recruiting
• University of California at Davis Medical Center
  Sacramento, California, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Patrick Flume, MD — Medical University of South Carolina
• Study coordinator: Rachael Buckingham, BS
• Email: Rachael.buckingham@seattlechildrens.org
• Phone: 206-884-7517

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older

  This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.

  Recruiting Early Phase 1 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07485543

• Inflammation, infection and treatments during severe cystic fibrosis flare-ups

  Researchers will follow people with cystic fibrosis who are at risk of severe lung flare-ups to see if symptoms, lung tests, and biological samples explain different responses to intravenous antibiotics.

  Recruiting University of Manchester · Cardiff and 5 other locations · NCT07484607

• VX-272 dose escalation in healthy adults

  This will test single and multiple increasing doses of the experimental drug VX-272 in healthy adults to see how safe it is and how the body handles it.

  Recruiting Phase 1 Vertex Pharmaceuticals Incorporated · Tempe, Arizona · NCT07437105

• Prevalence of smoking, passive smoke exposure, and vaping among adults with cystic fibrosis

  This project will see how common smoking, exposure to secondhand smoke, and vaping are among adults with cystic fibrosis followed at the Strasbourg Adult CF Center.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07342920

• Dose escalation of VX-581 to check safety and drug levels in healthy adults

  The trial will test increasing doses of VX-581 in healthy adults to see if it is safe and to measure how the body absorbs and clears the drug.

  Recruiting Phase 1 Vertex Pharmaceuticals Incorporated · Overland Park, Kansas · NCT07283770

• PALMIRE cohort: phenotyping inflammatory lung diseases to enable personalized care

  This project will collect clinical, imaging, and biological data from adults with asthma, COPD, bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, or interstitial lung disease to try to identify disease subtypes and markers that could guide more personalized care.

  Recruiting CHU de Reims · Reims · NCT07274631

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.