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

NCT02134301 | Completed Phase 1 DMC

• 2 other identifiers: TMC-ORI-11-012013-005415-26
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Gram-positive Bacterial Infections

Keywords

Oritavancin; Pediatrics; Gram-positive; Bacterial Infection; Confirmed; Suspected

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetic Parameters

  336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5

• Safety Endpoint

  Up to Day 60 post-dose

Study Arms (1)

Oritavancin

EXPERIMENTAL

Single-dose IV Oritavancin Diphosphate

Drug: Oritavancin

Interventions

Oritavancin DRUG

Oritavancin

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Participants 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. Participants 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 participants 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 participant at increased risk or is likely to interfere with study procedures or PK of the study drug.
• Participants 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.

Sponsors & Collaborators

• Melinta Therapeutics, LLC: lead

Study Sites (8)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

UCLA Harbor Medical Center

Torrance, California, 90502, United States

Location

Univ of Louisville, Norton Children's Research Institute

Louisville, Kentucky, 40202, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68114, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Gram-Positive Bacterial Infections; Bacterial Infections

Interventions

oritavancin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Study Director

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: May 1, 2014
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (8)