Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Phase 4

Recruiting

• Conditions: Cystic Fibrosis; Cystic Fibrosis Pulmonary Exacerbation

• Registration Number: NCT05548283
• Lead Sponsor: Chris Goss

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-9-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - All genders = 6 years of age at Visit 1<br><br> - Documentation of a CF diagnosis<br><br> - Clinician intent to treat index CF PEx with a planned 14-day course of IV<br> antimicrobials<br><br> - At least one documented Pa positive culture within two years prior to Visit 1<br><br>Exclusion Criteria:<br><br> - Participant is not pregnant<br><br> - No known renal impairment or history of solid organ transplantation<br><br> - No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6<br> weeks prior to Visit 1<br><br> - No use of investigational therapies, new CF transmembrane conductance regulator<br> (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks<br> prior to Visit 1<br><br> - No history of hypersensitivity, vestibular, or auditory toxicity with<br> aminoglycosides<br><br> - No more than one day of IV aminoglycosides administered for the current PEx<br> treatment prior to Visit 1

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study