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Trikafta/Kaftrio and Pseudomonas Aeruginosa

NCT05675592 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-01-11

No results posted yet for this study

Summary

The goal of this observational study o is to define whether, how and to what extent treatment with Trikafta/Kaftrio directly affects Pseudomonas aeruginosa in individuals with cystic fibrosis. The main questions it aims to answer are:

* whether Trikafta/Kaftrio affects the bacterial phenotypes and susceptibility to antibiotics;
* whether Trikafta/Kaftrio impacts the bacterial virulence. Participants will be asked the permission to store and analyze P. aeruginosa isolates collected from respiratory samples for usual care plans before the initiation of treatment with Trikafta/Kaftrio and after 12 and 18 months of treatment. The results of bacterial analysis will be matched with clinical data at the specific time-points.

We expect to define effects of Trikafta/Kaftrio on P. aeruginosa and identify bacterial phenotypes as possible risk factors for its efficacy.

Conditions

Sponsors & Collaborators

  • Ospedale Pediatrico Bambin Gesù

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Ospedale San Raffaele

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2023-11-16
Completion
2025-05-16

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05675592 on ClinicalTrials.gov