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Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier:
NCT02013141
First received: December 11, 2013
Last updated: July 17, 2017
Last verified: July 2017
  Purpose
This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes

Condition Intervention Phase
Gram-Positive Bacterial Infections Drug: Telavancin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 3 Months to 17 Years

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):

Primary Outcome Measures:
  • Pharmacokinetics- AUC (area under curve) [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Pharmacokinetics- Cmax [ Time Frame: 24 hours ]
  • Pharmacokinetics- Tmax [ Time Frame: 24 hours ]
  • Pharmacokinetics- t1/2 [ Time Frame: 24 hours ]
  • Pharmacokinetics- CLp (plasma clearance) [ Time Frame: 24 hours ]
  • AEs (adverse events) [ Time Frame: 24 hours ]

Estimated Enrollment: 36
Actual Study Start Date: December 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telavancin
Telavancin 10 mg/kg IV administered over one hour one time.
Drug: Telavancin
Other Names:
  • VIBATIV
  • TD-6424

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is aged >3 months to 17 years (inclusive) and has a weight within the 3rd to 97th percentile (inclusive) for age and sex
  • Subject requires or recently completed systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection

Exclusion Criteria:

  • Subject has an estimated creatinine clearance <50 mL/min/1.73 m2 (Schwartz equation)
  • Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients
  • Subject has clinically relevant cardiac abnormality, in the opinion of the investigator
  • Subject was treated with an investigational drug within 30 days or five half-lives, whichever is longer, before study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013141

Contacts
Contact: Mia Elliott 650-808-6000 MElliott@theravance.com
Contact: Trisha Huber 972-948-4391 THuber@theravance.com

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: David Speicher, M.D.         
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Bibiana Castaneda, MD Theravance Biopharma R & D, Inc.
  More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02013141     History of Changes
Other Study ID Numbers: 0101
Study First Received: December 11, 2013
Last Updated: July 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):
Gram positive bacteria
Telavancin
VIBATIV
Pediatric
Pharmacokinetics

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017