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.
Patients were screened to determine eligibility and to obtain a sputum culture. Eligible patients were randomized to either the standard or biofilm study arm. Antibiotic selection was performed centrally according to a standard algorithm using the susceptibility test results of the assigned study arm. On Day 0, patients were started on a 14-day course of two antibiotics as selected per protocol. Antibiotics were administered intravenously (IV) and/or orally. A follow-up phone call or visit occurred on Day 7. An end of treatment visit was conducted after completion of antibiotic therapy. A total of 39 patients were randomized. Many screened patients were ineligible for randomization based on microbiology results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
5-7.5 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
250 mg once daily
50 mg/kg every 8 hours, up to 2 grams every 8 hours
University of Iowa
Iowa City, Iowa, United States
Washington University St. Louis
St Louis, Missouri, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Microbiological efficacy: Change in P. aeruginosa density
Time frame: from enrollment (up to day -21) to end of treatment (day 12-14)
Clinical efficacy: Pre- to post-treatment change in FEV1
Time frame: from initiation (day 0) to end of treatment (day 12-14)
Safety: Adverse events, including new onset of acute pulmonary exacerbation and/or the need to change antibiotic therapy during the treatment period
Time frame: from enrollment (up to day -21) to end of treatment (day 12-14)
Feasibility: Average costs and time per assay; rate of patient withdrawal because resistance patterns preclude randomization; self-reported technician satisfaction
Time frame: during active enrollment (March 2004-November 2007)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
500 mg every 12 hours if weight \<50 kg 750 mg every 12 hours if weight ≥50 kg
40 mg/kg every 8 hours, up to 2 grams every 8 hours
100 mg/kg of piperacillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
100 mg/kg of ticarcillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
2.5-3.3 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States