Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections

Description

The purpose of this Phase 1 trial is to evaluate the PK, safety and tolerability of oritavancin in patients <18 years old with a confirmed or suspected bacterial infection.

Study Start Date

May 2014

Estimated Completion Date

December 2016

Interventions

  • Drug: Oritavancin

Specialties

  • Pediatrics: Clinical Pharmacology,Peds Infectious Disease
  • Infectious Disease: Antimicrobials,Peds Infectious Disease
  • Pharmacy: Antimicrobials

MeSH Terms

  • Bacterial Infections
  • Gram-Positive Bacterial Infections
  • Oritavancin

Study ID

The Medicines Company -- TMC-ORI-11-01

Status

Unknown

Trial ID

NCT02134301

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

60

Sponsor

The Medicines Company

Inclusion Criteria

  • Males and females <18 years of age
  • Neonates must be at least 34 weeks post-conception age
  • Parent or legal guardian has given informed consent, as appropriate
  • and pediatric patient has given verbal assent where appropriate.
  • Suspected or confirmed Gram positive bacterial infection receiving antibiotic therapy
  • Intravenous access to administer study drug
  • In the investigator's opinion, the patient will require hospitalization for at least 24 hours after the study drug is administered.

Exclusion Criteria

  • Septic shock or acute haemodynamic instability.
  • History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, or teicoplanin) or any of their excipients.
  • Currently using vancomycin or other glycopeptides
  • Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception or female patients of childbearing who are lactating or have a positive pregnancy test result at screening
  • Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period
  • Any surgical or medical condition which, in the opinion of the investigator, would put the patient at increased risk or is likely to interfere with study procedures or PK of the study drug.
  • Patients whom the investigator considers unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
  • Treatment with investigational medicinal product or investigational device within 30 days (or 5 times the half-life of the investigational medicine, whichever is longer) before enrollment and for the duration of the study.
  • Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, metabolic or cardiovascular disease.

Gender

Both

Ages

18 Years and younger

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
Stony Brook University Medical Center - Stony Brook, New York 22.8 miles Denise Ferraro FNP 631-444-8225 denise.ferraro@stonybrookmedicine.edu
Rainbow Babies and Childrens Hospital - Cleveland, Ohio 434.6 miles Susan Bergant RN 216-844-5112 susan.bergant@uhhospitals.org
Toledo Childrens Hospital - Toledo, Ohio 538.2 miles Mary Thomas 419-291-2191 Mary.Thomas3@ProMedica.org
Kosair Charities Pediatric Clinical Research Unit - Louisville, Kentucky 696.1 miles None None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,128.3 miles Robin Gibson RN 501-364-1542 gibsonrobina@uams.edu
University of Nebraska Medical Center - Omaha, Nebraska 1,182.2 miles Jenny Goodwin 402-559-0681 jennifer.goodwin@unmc.edu
Rady Childrens Hospital San Diego - San Diego, California 2,469.3 miles Sara Hingtgen RN MSN 858-966-8450 shingtgen@rchsd.org
CHOC Childrens - Orange, California 2,477.9 miles Claudia Enriquez 714-509-4791 cenriquez@CHOC.ORG
HarbourUCLA Medcial Center - Torrance, California 2,499.6 miles Samantha J Eells MPH 310-222-5693 seells@ucla.edu

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