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NCT Number: NCT05584982

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Lung Infection Bacterial Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AtbFinder

Device

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 outcomes

  1. Time to an exacerbation (in months)

    Time frame: Time Frame: up to 24 months

Secondary outcomes

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

    Time frame: Time Frame: up to 24 months

  2. 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

  3. 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

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

    Time frame: Time Frame: up to 24 months

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

    Time frame: Time Frame: up to 24 months

  6. Changes in weight (in kilograms)

    Time frame: Time Frame: up to 24 months

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

    Time frame: Time Frame: up to 24 months

Sponsors and collaborators

Lead sponsor

TGV-Dx

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2022
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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