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

TGV-Dx35 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis Lung Infection Bacterial

Interventions

AtbFinderDEVICE

In the present study, we provided a prospective evaluation of the effectiveness of antibiotics selected with AtbFinder compared to a retrospective analysis of antibiotic efficacy selected with conventional culture-based antibiotic susceptibility tets in patients with cystic fibrosis

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.