Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Western Reserve University
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Male or female ≥ 18 years of age.

• Confirmed diagnosis of CF based on the following criteria:

• positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or

• a genotype with two identifiable mutations consistent with CF or abnormal NPD, and

• one or more clinical features consistent with the CF phenotype.

• Chronic sputum producer able to spontaneously produce sputum

• FEV1 > 40% of predicted normal for age, gender, and height

• Previous use of any inhaled antibiotics within the last year

• Ability to provide written informed consent

• Ability to adhere to the protocol

Exclusion Criteria:

• Use of inhaled or intravenous vancomycin within two weeks of the study visit

• Known history of intolerance to inhaled vancomycin or inhaled albuterol.

• Known history of hypersensitivity to vancomycin or other glycopeptide antibiotics

• History of sputum culture with Burkholderia cepacia complex in the last two years.

• Pregnancy

• Woman who are lactating and not willing to stop nursing on the day of the study visit and the subsequent 48 hours.

• Current use of oral corticosteroids in doses exceeding the equivalent of 10mg of prednisone a day or 20mg of prednisone every other day.

• Patients not willing to hold other inhaled antibiotics (for example TOBI, Cayston, or Colistin) for at least 2 days prior to the study visit.

• Patients not willing to hold loop diuretics (i.e. furosemide, torsemide, ethacrynic acid) on the morning of the study visit.

• History of ABPA or reactive airways disease that has required treatment within the last year.

• Creatinine greater than 2.0 mg/dL within the last year.

• Oxygen saturation ≤ 92% on room air.

• History of patient reported hearing loss

• Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or adherence to the protocol.

• History of or listed for solid organ or hematological transplantation