- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03172793
Telavancin Pharmacokinetics in Cystic Fibrosis Patients
October 22, 2019 updated by: Joseph L. Kuti, PharmD
Pharmacokinetics and Tolerability of Telavancin at Differing Dosing Regimens in Cystic Fibrosis Adults Admitted With Acute Pulmonary Exacerbations
Due to emerging resistance, new antibiotic options are needed to treat CF acute pulmonary exacerbations caused by methicillin resistant Staphylococcus aureus (MRSA).
There is established evidence that adult patients with cystic fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients.
Telavancin is a lipoglycopeptide antibiotic that has activity against gram-positive bacteria including MRSA.
This study will determine the pharmacokinetics and tolerability of telavancin in 18 adult CF patients admitted for a pulmonary exacerbation at 1 of 4 participating hospitals in the US.
Study Overview
Detailed Description
Each participant will receive 3 doses of intravenous telavancin administered every 24 hours.
Up to three different doses of telavancin will be studied (n=6 per group).
Blood samples will be collected throughout the study to determine the pharmacokinetics of telavancin.
Each group will proceed after measurement of safety, tolerability, and pharmacokinetics of the lower dose group before it.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, United States, 46202
- IU Health University Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19134
- St. Christophers Hospital for Children
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center Shadyside
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 years or older
- Documented diagnosis of CF
- Acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment, as defined by treating provider
- If female, subjects must be non-pregnant and non-lactating. Females can be either not of a child-bearing potential or if of a child-bearing potential, on acceptable modes of birth control such as abstinence from sexual intercourse, oral/parenteral contraceptives, or barrier method
Exclusion Criteria:
- History of any moderate or severe hypersensitivity or allergic reaction to telavancin or any component of telavancin, or any glycopeptide (e.g., vancomycin) antibiotic (a history of red man syndrome with vancomycin is not an exclusion criteria)
- History of any solid organ transplantation within the last 12 months
- Moderate to severe renal dysfunction defined as a creatinine clearance (CLCR) < 50 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
- Oliguria (urine output < 0.4 mL/kg/hr for at least 12 hours, up to a total of <20 mL/hr) or significant alterations in fluid/electrolyte homeostasis in a 72 hour window before enrollment with a history of renal compromise
- A hemoglobin less than 8 gm/dl at baseline
- Anticipated length of hospital stay less than 4 days, which would prevent completion of dose administration and pharmacokinetic sampling
- Receiving intravenous vancomycin at the time of enrollment or anticipation of requiring intravenous vancomycin during study participation (Note. Other antibiotics targeting Gram-positive bacteria such as MRSA are permitted)
- Receiving an anticoagulant AND requires specific coagulation testing (prothrombin time/international normalized ratio, activated partial thromboplastin time, activated clotting time, or coagulation based factor x activity assay) within 24 hours of receiving a telavancin dose (Note. Although telavancin does not interfere with coagulation, it may interfere with some assays used to monitor coagulation)
- Requirement of concomitant administration of agents containing a cyclodextrin solubilizer such as intravenous voriconazole or itraconazole
- Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
- Planned or prior participation in any other interventional drug study within 30 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telavancin injection Dose 1 (7.5mg/kg)
The pharmacokinetics and tolerability of telavancin 7.5mg/kg q24h will be measured in 6 participants.
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Receive 3 doses of telavancin as described in arm/groups, followed by collection of blood for pharmacokinetic analyses.
Other Names:
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Experimental: Telavancin injection Dose 2 (10mg/kg)
After completion and analysis of 7.5mg/kg group, the next 6 participants will receive 10mg/kg q24h, and pharmacokinetics and tolerability will be measured.
|
Receive 3 doses of telavancin as described in arm/groups, followed by collection of blood for pharmacokinetic analyses.
Other Names:
|
Experimental: Telavancin injection Dose 3 (TBD)
The third arm will enroll 6 participants to receive the following dose of telavancin q24h: 7.5, 10, 12.5, or 15 mg/kg.
The final dose will be selected based on pharmacokinetic studies from first 12 participants, tolerability, and pharmacodynamic modeling.
|
Receive 3 doses of telavancin as described in arm/groups, followed by collection of blood for pharmacokinetic analyses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Telavancin Clearance
Time Frame: 1, 24, 25, 48, 49-49.08, 49.25-49.5, 50-51, 52-53, 55-56, 57-61, and 72 hours after start of dosing.
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This outcome measures the total body clearance (L/hr) of telavancin over the 4 day study.
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1, 24, 25, 48, 49-49.08, 49.25-49.5, 50-51, 52-53, 55-56, 57-61, and 72 hours after start of dosing.
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Telavancin Volume of Distribution
Time Frame: 1, 24, 25, 48, 49-49.08, 49.25-49.5, 50-51, 52-53, 55-56, 57-61, and 72 hours after start of dosing.
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This outcome measures the volume of distribution (L) of telavancin over the 4 day study.
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1, 24, 25, 48, 49-49.08, 49.25-49.5, 50-51, 52-53, 55-56, 57-61, and 72 hours after start of dosing.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: 4 days
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This outcome measures the safety and tolerability of telavancin over the 4 day study with specific attention to changes in chemistry, complete blood count, and liver function tests before and after treatment, as well as any participant reported adverse events.
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4 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph L Kuti, PharmD, Hartford Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2017
Primary Completion (Actual)
April 17, 2019
Study Completion (Actual)
April 17, 2019
Study Registration Dates
First Submitted
May 9, 2017
First Submitted That Met QC Criteria
May 30, 2017
First Posted (Actual)
June 1, 2017
Study Record Updates
Last Update Posted (Actual)
October 24, 2019
Last Update Submitted That Met QC Criteria
October 22, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHC-2017-0093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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