Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 January 2015 by Theravance Biopharma Antibiotics, Inc.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. Identifier:
First received: December 11, 2013
Last updated: January 5, 2015
Last verified: January 2015

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 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics- Cmax [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics- Tmax [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics- t1/2 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics- CLp [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • AEs [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: December 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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
Genders Eligible for Study:   Both
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) or body mass index (BMI, for subjects 2 to 17 years) within the 5th to 95th percentile (inclusive) for age and sex.

Subject requires intravenous antibiotics for:

  • Gram-positive bacterial infection OR
  • prophylaxis of Gram-positive infection OR
  • empiric therapy for suspected Gram-positive infection

Exclusion Criteria:

Subject has an estimated creatinine clearance <50 mL/min/1.73 m2 (Schwartz formula).

Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients.

Subject requires concomitant vancomycin treatment.

  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: Frederic Heerinckx 650-808-6400

United States, Ohio
Jeffrey Blumer Recruiting
Toledo, Ohio, United States, 43606
Contact: Jeffrey Blumer, MD         
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Study Director: Carla Washington, PhD Theravance Biopharma Antibiotics, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc. Identifier: NCT02013141     History of Changes
Other Study ID Numbers: 0101
Study First Received: December 11, 2013
Last Updated: January 5, 2015
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
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015