ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02134301
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Gram Positive Bacterial Infections Drug: Oritavancin Phase 1

Detailed Description:
This is a Phase 1, multicenter, open-label, PK, safety and tolerability study of oritavancin in pediatric patients (<18 years of age) with suspected or diagnosed Gram-positive bacterial infections or pediatric patients requiring peri-operative prophylactic antibiotics. Approximately 52 patients will be enrolled at 5-10 US centers. This study will include 5 age cohorts and patients will be entered in a stepwise approach starting with the older age cohort (12-<18 years). The starting dose will be IV oritavancin 15 mg/kg. The safety, tolerability and PK data will be reviewed at the completion of each cohort to ensure safety and determine the appropriate dose for the next age cohort. At least 8 patients will be enrolled in each cohort except for the birth to <3 month age cohort which will have at least 16 patients enrolled. Three PK samples will be collected over 14 days. The safety follow-up will complete with a 60-day phone call to the caregiver.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Patients Less Than 18 Years of Age With Suspected or Confirmed Bacterial Infections (ORKIDS)
Study Start Date : May 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oritavancin

Arm Intervention/treatment
Experimental: Oritavancin
Single-Dose IV Oritavancin Diphosphate
Drug: Oritavancin



Primary Outcome Measures :
  1. Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC]) [ Time Frame: 336 hours post infusion start time ]
    PK parameters (AUC)


Secondary Outcome Measures :
  1. Pharmacokinetic Parameters [ Time Frame: 336 hours post infusion start time ]
    PK parameters (Cmax, half-life, tmax, volume of distribution and clearance)

  2. Safety Endpoint [ Time Frame: Up to Day 60 post-dose ]
    Safety of oritavancin assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events (SAEs) up to 60 days following termination of the study drug infusion.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 diagnosed Gram positive bacterial infection for which the subject is receiving standard antibiotic therapy; or peri-operative prophylactic use of antibiotics
  • Intravenous access to administer study drug
  • The subject will be observed in the emergency room or hospital for at least 1 hour after the study drug infusion is completed.

Exclusion Criteria:

  • Septic shock or acute haemodynamic instability.
  • History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, dalbavancin, televancin, or teicoplanin) or any of their excipients.
  • Subjects who have taken vancomycin, telavancin, teicoplanin or other glycopeptide within 24 hours of screening or who are anticipated to need these drugs within 48 hours after administration of study drug. Subjects who have taken dalbavancin are excluded if taken within the previous 2 weeks or who are anticipated to need dalbavancin within 48 hours after administration of study drug.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134301


Contacts
Contact: Karen Fusaro 908-617-1319

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Robin Gibson, RN    501-364-1542    gibsonrobina@uams.edu   
Principal Investigator: Jose R Romero, MD         
United States, California
CHOC Children's Recruiting
Orange, California, United States, 92868
Contact: Claudia Enriquez    714-509-4791    cenriquez@CHOC.ORG   
Principal Investigator: Antonio Arrieta, MD         
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Sara Hingtgen, RN, MSN    858-966-8450    shingtgen@rchsd.org   
Contact: Mike Farrell, RN, BSN    858-966-8450    mfarrell@rchsd.org   
Principal Investigator: John Bradley, MD         
Harbour-UCLA Medcial Center Completed
Torrance, California, United States, 90509
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Claudia Espinosa, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Jenny Goodwin    402-559-0681    jennifer.goodwin@unmc.edu   
Principal Investigator: Kari A Simonsen, MD         
United States, New York
Stony Brook University Medical Center Withdrawn
Stony Brook, New York, United States, 11794
United States, Ohio
Rainbow Babies and Children's Hospital Completed
Cleveland, Ohio, United States, 44106
Toledo Children's Hospital Terminated
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Investigators
Study Director: Karen Fusaro Melinta Therapeutics, Inc.

Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02134301     History of Changes
Other Study ID Numbers: TMC-ORI-11-01
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Melinta Therapeutics, Inc.:
oritavancin
pediatrics
gram positive
bacterial infection
Confirmed
Suspected

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Oritavancin
Anti-Bacterial Agents
Anti-Infective Agents