drugset / Trial / NCT00153634
Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)
RandomizedParallel-groupOpen-labelTreatment
Summary
This was a randomized multi-center clinical trial to compare the microbiological efficacy, clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P. aeruginosa sputum isolates to guide antibiotic selection for treatment of airway infection in clinically stable patients with CF.
Timeline
- Start
- 2004-03
- Primary completion
- —
- Completion
- 2007-11
Publications
- Background Moskowitz SM, Foster JM, Emerson J, Burns JL. Clinically feasible biofilm susceptibility assay for isolates of Pseudomonas aeruginosa from patients with cystic fibrosis. J Clin Microbiol. 2004 May;42(5):1915-22. doi: 10.1128/JCM.42.5.1915-1922.2004.
- Background Moskowitz SM, Foster JM, Emerson JC, Gibson RL, Burns JL. Use of Pseudomonas biofilm susceptibilities to assign simulated antibiotic regimens for cystic fibrosis airway infection. J Antimicrob Chemother. 2005 Nov;56(5):879-86. doi: 10.1093/jac/dki338. Epub 2005 Sep 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amikacin | Small molecule | 5 mg/kg | Intravenous |
| Subject | Amikacin | Small molecule | 7.5 mg/kg | Intravenous |
| Subject | Amoxicillin | Other / unclassified | 100 mg/kg | Intravenous |
| Subject | Azithromycin | Small molecule | 250 mg | Oral |
| Subject | Ceftazidime | Small molecule | 50 mg/kg | Intravenous |
| Subject | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Subject | Ciprofloxacin | Small molecule | 750 mg | Oral |
| Subject | Meropenem | Small molecule | 40 mg/kg | Intravenous |
| Subject | Tobramycin | Small molecule | 2.5 mg/kg | Intravenous |
| Subject | Tobramycin | Small molecule | 3.3 mg/kg | Intravenous |
| Subject | ticarcillin-clavulanate | Unknown | 100 mg/kg | Intravenous |