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

Study Overview
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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.

Official Title
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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

Conditions
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Cystic Fibrosis, Lung Infection Bacterial

Intervention / Treatment
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* Device: AtbFinder


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AtbFinder-1<br>persons with cystic fibrosis to whom AtbFinder was used to formulate an individualized antibiotic regimen | Device: AtbFinder<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to an exacerbation (in months) |  | Time Frame: up to 24 months | 

Secondary Outcome Measures

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