NCT00153634

Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)

Standard vs. Biofilm Susceptibility Testing in CF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cystic Fibrosis
• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	IV amikacin	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
DRUG	PO azithromycin	250 mg once daily
DRUG	IV ceftazidime	50 mg/kg every 8 hours, up to 2 grams every 8 hours
DRUG	PO ciprofloxacin	500 mg every 12 hours if weight \<50 kg 750 mg every 12 hours if weight ≥50 kg
DRUG	IV meropenem	40 mg/kg every 8 hours, up to 2 grams every 8 hours
DRUG	IV piperacillin-tazobactam	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
DRUG	IV ticarcillin-clavulanate	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
DRUG	IV tobramycin	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

Timeline

• Start date: 2004-03-01
• Completion: 2007-11-01
• First posted: 2005-09-12
• Last updated: 2008-03-13

Locations

8 sites across 1 country: United States