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

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ClinicalTrials.gov Identifier: NCT02013141
Recruitment Status : Recruiting
First Posted : December 17, 2013
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Gram-Positive Bacterial Infections Drug: Telavancin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Actual Study Start Date : December 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Telavancin
Telavancin 10 mg/kg IV administered over one hour one time.
Drug: Telavancin
Other Names:
  • VIBATIV
  • TD-6424



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

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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013141


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

Locations
United States, California
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Antonio C. Arrieta, M.D.         
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Bibiana Castaneda, MD Theravance Biopharma R & D, Inc.

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02013141     History of Changes
Other Study ID Numbers: 0101
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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