Phase 4 Cystic Fibrosis Trial, Recruiting NCT05548283 Sponsor: Chris Goss Condition: Cystic Fibrosis
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Phase 4 Cystic Fibrosis Trial, Recruiting

NCT05548283
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 6 years of age or older (any gender)
  • You have been formally diagnosed with cystic fibrosis (CF)
  • Your doctor plans to treat your current CF lung flare-up with a 14-day course of antibiotics given through a vein (IV)
  • You have had at least one positive test result for a bacteria called Pseudomonas aeruginosa within the past two years

Who may not be able to join:

  • You are currently pregnant
  • You have known kidney problems or have previously received a transplanted organ (such as a kidney, liver, or lung)
  • You have received IV antibiotics, been admitted to an intensive care unit (ICU), or experienced a collapsed lung or significant coughing up of blood within the past 6 weeks
  • You have used an experimental treatment, started a new type of CF medication (called a CFTR modulator), or received treatment for a specific type of lung infection (called NTM) within the past 4 weeks
  • You have a history of bad reactions, balance or hearing problems caused by a type of antibiotic called aminoglycosides (confirm with trial site)
  • You have already received more than one day of IV aminoglycoside antibiotics for your current CF flare-up before joining the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Patrick Flume, MD, Medical University of South Carolina

Phone: 206-884-7517

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Chris Goss
Registry
ClinicalTrials.gov
Start date
23 April 2023
Est. completion
31 May 2027

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study; Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov