Status:
WITHDRAWN
Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Methicillin-resistant Staphylococcus Aureus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.
Detailed Description
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in patients with cystic fibrosis has increased dramatically over the last decade. Epidemiologic evidence sugg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01509339
Start Date
January 1 2012
End Date
December 23 2021
Last Update
January 12 2022
Active Locations (1)
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1
Rainbow Babies and Children's Hospital, Univeristy Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106