Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01509339
• Date of registration: 09/01/2012
• Prospective Registration: No
• Primary sponsor: Case Western Reserve University
• Public title: Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis
• Scientific title: Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis
• Date of first enrolment: January 2012
• Target sample size: 10
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01509339
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Elliott C Dasenbrook, MD MHS
• Affiliation: Case Western Reserve University School of Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Methicillin-resistant Staphylococcus Aureus

Intervention(s)

Drug: Vancomycin

Primary Outcome(s)

Area Under Curve (AUC) [Time Frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin]

Secondary Outcome(s)

Serum Vancomycin Peak Concentration [Time Frame: 60 minutes]

Maximum Concentration [Time Frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin]

Change in Patient Symptoms [Time Frame: 6 hours]

Time to Peak Concentration [Time Frame: Predose, 5 minutes, one hour, 2 hours, and 6 hours after completion of 250mg of inhaled vancomycin]

Adverse Events [Time Frame: 6 hours]

Change in FEV1% Predicted [Time Frame: 30 minutes]

Change in Sputum Cell Counts [Time Frame: 6 hours]

Oxygen Saturation [Time Frame: 5 minutes]

Secondary ID(s)

iVCM 1.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation Therapeutics