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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Gram Positive Bacterial Infections
• Intervention / Treatment: Drug: Oritavancin

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 54 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
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Richard J Lazauskas, DC; Phone Number: 1-908-617-1381; Email: rlazauskas@melinta.com
• Study Contact Backup: Name: William Waverczak, MS; Phone Number: 1-908-617-1308; Email: wwaverczak@melinta.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Completed
      • Arkansas Children's Hospital
  • California
    • Orange, California, United States, 92868
      • Completed
      • Childrens Hospital of Orange County
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital
      • Principal Investigator: John Bradley, MD
      • Contact: Mary Jordan, RN, MSN; Email: mjordan@rchsd.org
    • Torrance, California, United States, 90502
      • Completed
      • UCLA Harbor Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Univ of Louisville, Norton Children's Research Institute
      • Contact: Andrew Michael; Email: andrew.michael@louisville.edu
      • Principal Investigator: Janice Sullivan, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • University of Nebraska Medical Center
      • Principal Investigator: Kari A Simonsen, MD
      • Contact: Laura Fischer; Email: laura.fischer@unmc.edu
  • New York
    • Stony Brook, New York, United States, 11794
      • Withdrawn
      • Stony Brook University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Completed
      • Rainbow Babies and Children's Hospital
    • Toledo, Ohio, United States, 43606
      • Terminated
      • Toledo Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oritavancin; Single-Dose IV Oritavancin Diphosphate	Drug: Oritavancin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC])	PK parameters (AUC)	336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	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.	Up to Day 60 post-dose
Pharmacokinetic Parameters	PK parameters (Cmax, half-life, tmax, volume of distribution and clearance)	336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5

Collaborators and Investigators

• Sponsor: Melinta Therapeutics, LLC
• Investigators: Study Director: Study Director, Melinta Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimated): May 9, 2014

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pediatrics; bacterial infection; gram positive; oritavancin; Confirmed; Suspected
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections; Gram-Positive Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Oritavancin
• Other Study ID Numbers: TMC-ORI-11-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED