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

December 5, 2025 updated by: Melinta Therapeutics, LLC

An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age With Suspected or Confirmed Bacterial Infections

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, multicenter, open-label, PK, safety and tolerability study of oritavancin in pediatric participants (<18 years of age) with suspected or diagnosed Gram-positive bacterial infections or pediatric participants requiring peri-operative prophylactic antibiotics. Approximately 54 participants will be enrolled at 5-10 United States centers. This study will include 5 age cohorts and participants will be entered in a stepwise approach starting with the older age cohort (12 to <18 years). The starting dose will be intravenous (IV) oritavancin 15 milligrams/kilogram. 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 participants will be enrolled in each cohort except for the birth to <3 month age cohort which will have at least 16 participants 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • San Diego, California, United States, 92123
        • Rady Children's Hospital
      • Torrance, California, United States, 90502
        • UCLA Harbor Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Univ of Louisville, Norton Children's Research Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • University of Nebraska Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital
      • Toledo, Ohio, United States, 43606
        • Toledo Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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.

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oritavancin
Single-dose IV Oritavancin Diphosphate
Drug: Oritavancin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC])
Time Frame: 336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
PK parameters (AUC)
336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to Day 60 post-dose
Pharmacokinetic Parameters
Time Frame: 336 hours post infusion start time for Cohorts 1-4 and 168 hours for Cohort 5
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Melinta Therapeutics, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Melinta Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMC-ORI-11-01
  • 2013-005415-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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