Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 1 to 17 Years

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Theravance Biopharma Antibiotics, Inc.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. Identifier:
First received: December 11, 2013
Last updated: June 24, 2016
Last verified: June 2016
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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 1 to 17 Years

Resource links provided by NLM:

Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Pharmacokinetics- AUC (area under curve) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics- Cmax [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics- Tmax [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics- t1/2 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics- CLp (plasma clearance) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • AEs (adverse events) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: December 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (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:
  • TD-6424


Ages Eligible for Study:   1 Year to 17 Years   (Child)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subject is 1 to 17 years (inclusive) and has a height/length/weight (for subjects between 12 and 23 months) within the 3rd to 97th percentile (inclusive) for age and sex.

Subject requires systemic antibiotics for:

  • known or suspended Gram-positive bacterial infection OR
  • prophylaxis of bacterial infection OR
  • empiric therapy for 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.
  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 identifier: NCT02013141

Contact: Mia Elliott 650-808-6000

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

Responsible Party: Theravance Biopharma Antibiotics, Inc. Identifier: NCT02013141     History of Changes
Other Study ID Numbers: 0101 
Study First Received: December 11, 2013
Last Updated: June 24, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Gram positive bacteria

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on January 18, 2017