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

This study is not yet open for participant recruitment.
Verified December 2013 by Theravance, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT02013141
First received: December 11, 2013
Last updated: December 16, 2013
Last verified: December 2013
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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, 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: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telavancin Drug: Telavancin
Other Name: VIBATIV

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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

Contacts
Contact: Frederic Heerinckx 650-808-6400 Fheerinckx@theravance.com

Locations
United States, California
TBD Not yet recruiting
TBD, California, United States, 94080
Contact: TBD TBD         
Sponsors and Collaborators
Theravance, Inc.
  More Information

No publications provided

Responsible Party: Theravance, Inc.
ClinicalTrials.gov Identifier: NCT02013141     History of Changes
Other Study ID Numbers: 0101
Study First Received: December 11, 2013
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance, Inc.:
Gram positive bacteria
Telavancin
VIBATIV
Pediatric
Pharmacokinetics

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014