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This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AtbFinder-1 | Experimental | persons with cystic fibrosis to whom AtbFinder was used to formulate an individualized antibiotic regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to an exacerbation (in months) | Time Frame: up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes in forced expiratory volume from baseline to end of study | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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2022-2023
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| 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 |
| 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 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |