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

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.

Conditions

• Cystic Fibrosis
• Chronic Bronchitis

Interventions

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

Sponsors & Collaborators

• Cystic Fibrosis Foundation

  collaborator OTHER

• Seattle Children's Hospital

  lead OTHER

Principal Investigators

• Samuel M Moskowitz, MD · Seattle Children's Hospital

• Jane L Burns, MD · Children's Hospital and Regional Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-03-31

Completion

2007-11-30

Countries

• United States

Study Locations