Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections
Primary Purpose
Gram Positive Bacterial Infections
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oritavancin
Sponsored by
About this trial
This is an interventional treatment trial for Gram Positive Bacterial Infections focused on measuring oritavancin, pediatrics, gram positive, bacterial infection, Confirmed, Suspected
Eligibility 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.
Sites / Locations
- Arkansas Children's Hospital
- Childrens Hospital of Orange County
- Rady Children's HospitalRecruiting
- UCLA Harbor Medical Center
- Univ of Louisville, Norton Children's Research InstituteRecruiting
- University of Nebraska Medical CenterRecruiting
- Stony Brook University Medical Center
- Rainbow Babies and Children's Hospital
- Toledo Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oritavancin
Arm Description
Single-Dose IV Oritavancin Diphosphate
Outcomes
Primary Outcome Measures
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC])
PK parameters (AUC)
Secondary Outcome Measures
Pharmacokinetic Parameters
PK parameters (Cmax, half-life, tmax, volume of distribution and clearance)
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.
Full Information
NCT ID
NCT02134301
First Posted
May 7, 2014
Last Updated
September 1, 2023
Sponsor
Melinta Therapeutics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02134301
Brief Title
Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections
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 Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melinta Therapeutics, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram Positive Bacterial Infections
Keywords
oritavancin, pediatrics, gram positive, bacterial infection, Confirmed, Suspected
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oritavancin
Arm Type
Experimental
Arm Description
Single-Dose IV Oritavancin Diphosphate
Intervention Type
Drug
Intervention Name(s)
Oritavancin
Primary Outcome Measure Information:
Title
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC])
Description
PK parameters (AUC)
Time Frame
336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameters
Description
PK parameters (Cmax, half-life, tmax, volume of distribution and clearance)
Time Frame
336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
Title
Safety Endpoint
Description
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.
Time Frame
Up to Day 60 post-dose
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard J Lazauskas, DC
Phone
1-908-617-1381
Email
rlazauskas@melinta.com
First Name & Middle Initial & Last Name or Official Title & Degree
William Waverczak, MS
Phone
1-908-617-1308
Email
wwaverczak@melinta.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Melinta Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Completed
Facility Name
Childrens Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Completed
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Jordan, RN, MSN
Email
mjordan@rchsd.org
First Name & Middle Initial & Last Name & Degree
John Bradley, MD
Facility Name
UCLA Harbor Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Completed
Facility Name
Univ of Louisville, Norton Children's Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Michael
Email
andrew.michael@louisville.edu
First Name & Middle Initial & Last Name & Degree
Janice Sullivan, MD
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Fischer
Email
laura.fischer@unmc.edu
First Name & Middle Initial & Last Name & Degree
Kari A Simonsen, MD
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Completed
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Terminated
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections
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