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

Information source: Seattle Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis; Chronic Bronchitis

Intervention: IV amikacin (Drug); PO azithromycin (Drug); IV ceftazidime (Drug); PO ciprofloxacin (Drug); IV meropenem (Drug); IV piperacillin-tazobactam (Drug); IV ticarcillin-clavulanate (Drug); IV tobramycin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Seattle Children's Hospital

Official(s) and/or principal investigator(s):
Samuel M Moskowitz, MD, Principal Investigator, Affiliation: Seattle Children's Hospital
Jane L Burns, MD, Study Chair, Affiliation: Children's Hospital and Regional Medical Center


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.

Clinical Details

Official title: Standard vs. Biofilm Susceptibility Testing in CF

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Microbiological efficacy: Change in P. aeruginosa density

Secondary outcome:

Clinical efficacy: Pre- to post-treatment change in FEV1

Safety: Adverse events, including new onset of acute pulmonary exacerbation and/or the need to change antibiotic therapy during the treatment period

Feasibility: Average costs and time per assay; rate of patient withdrawal because resistance patterns preclude randomization; self-reported technician satisfaction

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.


Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of CF based on the following: sweat chloride > 60 mEq/L (by quantitative

pilocarpine iontophoresis), or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.

- Age ≥ 14 years (changed from ≥ 18 years by protocol amendment).

- Able to expectorate sputum at screening.

- History of persistent positivity for P. aeruginosa on respiratory culture (at least

three positive oropharyngeal (OP), sputum and/or bronchoscopy cultures in the 24 months prior to screening).

- Able to reproducibly perform pulmonary function testing.

- Clinically stable at screening, with no evidence of pulmonary exacerbation.

- Written informed consent provided.

Exclusion Criteria:

- Sputum culture negative for P. aeruginosa or density less than 10E5 CFU/gm at


- Sputum culture positive for B. cepacia at screening.

- Presence of P. aeruginosa in sputum with off-scale resistance to all antibiotics by

either method of susceptibility testing at screening. (changed from multiply-resistant P. aeruginosa by protocol amendment)

- History of B. cepacia positive respiratory culture within 24 months prior to


- Hospitalization or treatment for a pulmonary exacerbation within 2 months prior to


- Administration of parenteral anti-pseudomonal antibiotics within 2 months prior to


- Treatment with oral or inhaled anti-pseudomonal antibiotics, or azithromycin or other

macrolides within 14 days prior to screening.

- History of allergy (urticarial rash, diffuse erythroderma, serum sickness) to more

than two groups of antibiotics (aminoglycosides, penicillins, cephalosporins, monobactams, macrolides, or quinolones) that are a therapeutic option.

- History of anaphylaxis or other life threatening complication to any antibiotic in

the six groups that are a therapeutic option.

- History of abnormal renal function (serum creatinine > 1. 5 x upper limit of normal)

within one year of enrollment.

- History of abnormal liver function tests (> 2. 5 x upper limit of normal) within one

year of enrollment.

- Clinically documented hearing loss that precludes treatment with aminoglycosides.

- Post lung transplantation.

- Positive pregnancy test or female who is lactating or is not practicing an acceptable

method of birth control.

- Presence of a condition or abnormality that in the opinion of an investigator would

compromise the safety of the patient or the quality of the data.

- Administration of any investigational agent within 30 days prior to screening.

Locations and Contacts

University of Iowa, Iowa City, Iowa 52242, United States

Washington University St. Louis, St. Louis, Missouri 63110, United States

University of Cincinnati, Cincinnati, Ohio 45267-0557, United States

Ohio State University, Columbus, Ohio 43205, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Children's Hospital and Regional Medical Center, Seattle, Washington 98105-0371, United States

University of Washington Medical Center, Seattle, Washington 98195, United States

Additional Information

Related publications:

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.

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. Epub 2005 Sep 27.

Starting date: March 2004
Last updated: March 12, 2008

Page last updated: August 23, 2015

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