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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05584982
• Other study ID #: Atbfinder-CF1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 12, 2022

Study information

• Verified date: October 2022
• Source: TGV-Dx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TGV-Dx

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to an exacerbation (in months)		Time Frame: up to 24 months
Secondary	Evaluate changes in forced expiratory volume from baseline to end of study		Time Frame: up to 24 months
Secondary	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
Secondary	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
Secondary	Changes in blood white blood cell count (10*9 mg/L)		Time Frame: up to 24 months
Secondary	Changes in blood C-reactive protein (in mg/L)		Time Frame: up to 24 months
Secondary	Changes in weight (in kilograms)		Time Frame: up to 24 months
Secondary	Changes in body mass index calculated as weight (in kilograms) divided by height squared (m2).		Time Frame: up to 24 months