Overview

This trial is active, not recruiting.

Conditions cystic fibrosis, methicillin-resistant staphylococcus aureus
Treatment vancomycin
Phase phase 1
Sponsor Case Western Reserve University
Collaborator Cystic Fibrosis Foundation
Start date January 2012
End date May 2013
Trial size 10 participants
Trial identifier NCT01509339, iVCM 1.0

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
250 mg vancomycin in 5cc sterile water will be inhaled once. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.
vancomycin Nebulized vancomycin
250 mg vancomycin in 5cc sterile water will be inhaled once. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.

Primary Outcomes

Measure
Area Under Curve (AUC)
time frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin

Secondary Outcomes

Measure
Change in FEV1% Predicted
time frame: 30 minutes
Change in Patient Symptoms
time frame: 6 hours
Change in Sputum Cell Counts
time frame: 6 hours
Serum Vancomycin Peak Concentration
time frame: 60 minutes
Oxygen Saturation
time frame: 5 minutes
Adverse Events
time frame: 6 hours
Maximum Concentration
time frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin
Time to Peak Concentration
time frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis
Principal investigator Elliott C Dasenbrook, MD MHS
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 suggests that persistent infection with MRSA may result in an increased rate of decline in FEV1 and shortened survival. Treatment of MRSA is a top priority. Inhaled antibiotics offer the advantage of high concentrations of antibiotic at the site of infection (the airway) while minimizing systemic side effects. Vancomycin is a glycopeptide antibiotic that has activity against MRSA. Anecdotal and retrospective peer-reviewed studies have demonstrated that inhaled vancomycin is safe and potentially effective in patients with cystic fibrosis and MRSA airway infection. Data evaluating the pharmacokinetics of vancomycin in sputum are needed before pursuing treatment trials.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Case Western Reserve University.