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

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Seattle Children's Healthcare System

Status

Completed

Conditions

Chronic Bronchitis
Cystic Fibrosis

Treatments

Drug: IV tobramycin
Drug: IV meropenem
Drug: PO azithromycin
Drug: PO ciprofloxacin
Drug: IV amikacin
Drug: IV piperacillin-tazobactam
Drug: IV ceftazidime
Drug: IV ticarcillin-clavulanate

Study type

Interventional

Funder types

Other

Identifiers

NCT00153634
BURNS03A0

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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 screening.
  • 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 screening.
  • Hospitalization or treatment for a pulmonary exacerbation within 2 months prior to screening.
  • Administration of parenteral anti-pseudomonal antibiotics within 2 months prior to screening.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

1
Experimental group
Description:
Antibiotic regimen assignment based on biofilm susceptibility test results
Treatment:
Drug: IV ticarcillin-clavulanate
Drug: IV piperacillin-tazobactam
Drug: IV ceftazidime
Drug: IV amikacin
Drug: PO ciprofloxacin
Drug: PO azithromycin
Drug: IV meropenem
Drug: IV tobramycin
2
Active Comparator group
Description:
Antibiotic regimen assignment based on conventional susceptibility test results
Treatment:
Drug: IV ticarcillin-clavulanate
Drug: IV piperacillin-tazobactam
Drug: IV ceftazidime
Drug: IV amikacin
Drug: PO ciprofloxacin
Drug: PO azithromycin
Drug: IV meropenem
Drug: IV tobramycin

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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