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. (see Contacts and Locations)
Verified July 2014 by Theravance BioPharma US, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance BioPharma US, Inc.
ClinicalTrials.gov Identifier:
NCT02013141
First received: December 11, 2013
Last updated: July 22, 2014
Last verified: July 2014
  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 BioPharma US, 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: July 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
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: 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 BioPharma US, Inc.
  More Information

No publications provided

Responsible Party: Theravance BioPharma US, Inc.
ClinicalTrials.gov Identifier: NCT02013141     History of Changes
Other Study ID Numbers: 0101
Study First Received: December 11, 2013
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 29, 2014