Cystic Fibrosis, Lung Infection Bacterial
Conditions
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.
Interventions
DEVICEAtbFinder
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
Sponsors
TGV-Dx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to an exacerbation (in months) | Time Frame: up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 |
| Evaluate changes in forced expiratory volume from baseline to end of study | 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 |
| 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 |
Outcome results
None listed