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

Primary Purpose

Cystic Fibrosis, Lung Infection Bacterial

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

AtbFinder

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AtbFinder-1

Arm Description

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

Outcomes

Primary Outcome Measures

Time to an exacerbation (in months)

Secondary Outcome Measures

Evaluate changes in forced expiratory volume from baseline to end of study

Changes in Pseudomonas aeruginosa load (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment

Changes in bacterial load of isolated organisms (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment

Changes in blood white blood cell count (10*9 mg/L)

Changes in blood C-reactive protein (in mg/L)

Changes in weight (in kilograms)

Changes in body mass index calculated as weight (in kilograms) divided by height squared (m2).

Full Information

NCT ID

NCT05584982

First Posted

October 12, 2022

Last Updated

October 14, 2022

Sponsor

TGV-Dx

1. Study Identification

Unique Protocol Identification Number

NCT05584982

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

October 12, 2022 (Actual)

Study Completion Date

October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TGV-Dx

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Lung Infection Bacterial

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AtbFinder-1

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

AtbFinder

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to an exacerbation (in months)

Time Frame

Time Frame: up to 24 months

Secondary Outcome Measure Information:

Title

Evaluate changes in forced expiratory volume from baseline to end of study

Time Frame

Time Frame: up to 24 months

Title

Changes in Pseudomonas aeruginosa load (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment

Time Frame

Time Frame: up to 24 months

Title

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

Time Frame: up to 24 months

Title

Changes in blood white blood cell count (10*9 mg/L)

Time Frame

Time Frame: up to 24 months

Title

Changes in blood C-reactive protein (in mg/L)

Time Frame

Time Frame: up to 24 months

Title

Changes in weight (in kilograms)

Time Frame

Time Frame: up to 24 months

Title

Changes in body mass index calculated as weight (in kilograms) divided by height squared (m2).

Time Frame

Time Frame: up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

2022-2023

Learn more about this trial

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

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