Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis

TGV-Dx

Status

Completed

Conditions

Lung Infection Bacterial

Cystic Fibrosis

Treatments

Device: AtbFinder

Study type

Interventional

Funder types

Industry

Identifiers

NCT05584982

Atbfinder-CF1

Details and patient eligibility

About

This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.

Full description

This pilot study entitled "Clinical Performance of the AtbFinder® diagnostic test system for selection of antibiotic therapy in persons with cystic fibrosis " was designed to demonstrate the clinical performance of antibiotics selected with the AtbFinder® for the treatment of lung infections in persons with cystic fibrosis.

Enrollment

35 patients

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of cystic fibrosis based on sweat chloride levels = or > 60, or genetic testing showing 2 pathogenic mutations.
Ability to provide a clinical sample (expectorated sputum, throat culture or bronchoalveolar lavage) prior to the start of the antibiotic treatment.
Prior treatment of a pulmonary exacerbation with systemic antibiotics in the preceding year.

Exclusion criteria

Inability to meet any of the above inclusion criteria.
Systemic therapy with an antibiotic or corticosteroids in the 3 weeks preceding enrollment in the study, except those on chronic inhaled antibiotics.
Primary or secondary (drug- or condition-induced) immune compromise.
Creatinine > 2 x upper limit of normal for age.
Previous participation in this study in the prior 28 days.