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

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Lung Infection Bacterial
• Interventions: Device: AtbFinder

• Registration Number: NCT05584982
• Lead Sponsor: TGV-Dx

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2022-10
• Primary Completion: 2022-10-12
• Study Completion: 2022-10-12
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AtbFinder-1	AtbFinder	persons with cystic fibrosis to whom AtbFinder was used to formulate an individualized antibiotic regimen

Primary Outcome Measures

Name	Time	Method
Time to an exacerbation (in months)	Time Frame: up to 24 months

Secondary Outcome Measures

Name	Time	Method
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
Evaluate changes in forced expiratory volume from baseline to end of study	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 body mass index calculated as weight (in kilograms) divided by height squared (m2).	Time Frame: up to 24 months
Changes in weight (in kilograms)	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