Clinical trial NCT05584982: Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
Official title: Open-label, Single-arm, Investigator-Initiated Clinical Study to Investigate the Performance of the AtbFinder® Diagnostic Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lung Infection Bacterial
Lead sponsor: TGV-Dx
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to an exacerbation (in months)
timeFrame: Time Frame: up to 24 months
Secondary outcomes:
measure: Evaluate changes in forced expiratory volume from baseline to end of study
timeFrame: Time Frame: up to 24 months
measure: Changes in Pseudomonas aeruginosa load (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment
timeFrame: Time Frame: up to 24 months
measure: Changes in bacterial load of isolated organisms (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment
timeFrame: Time Frame: up to 24 months
measure: Changes in blood white blood cell count (10*9 mg/L)
timeFrame: Time Frame: up to 24 months
measure: Changes in blood C-reactive protein (in mg/L)
timeFrame: Time Frame: up to 24 months
measure: Changes in weight (in kilograms)
timeFrame: Time Frame: up to 24 months
measure: Changes in body mass index calculated as weight (in kilograms) divided by height squared (m2).
timeFrame: Time Frame: up to 24 months
Other outcomes:
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