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

NCT ID: NCT05584982

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-10-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Cystic Fibrosis Lung Infection Bacterial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AtbFinder-1

persons with cystic fibrosis to whom AtbFinder was used to formulate an individualized antibiotic regimen

Group Type EXPERIMENTAL

AtbFinder

Intervention Type DEVICE

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

Interventions

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AtbFinder

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

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TGV-Dx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Atbfinder-CF1

Identifier Type: -

Identifier Source: org_study_id

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