COMPLETED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2014-05

Study Completion:2025-11-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT02134301

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.

Ages Eligible for Study:Not specified to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Study Director

STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Study Locations (Sites)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

Rady Children's Hospital

San Diego, California, 92123

United States

UCLA Harbor Medical Center

Torrance, California, 90502

United States

Univ of Louisville, Norton Children's Research Institute

Louisville, Kentucky, 40202

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68114

United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106

United States

Toledo Children's Hospital

Toledo, Ohio, 43606

United States

Collaborators and Investigators

Sponsor: Melinta Therapeutics, LLC

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 Registration Dates

Study Start Date2014-05

Study Completion Date2025-11-04

Study Record Updates

Study Start Date2014-05

Study Completion Date2025-11-04

Terms related to this study

Keywords Provided by Researchers

Oritavancin
Pediatrics
Gram-positive
Bacterial Infection
Confirmed
Suspected

Additional Relevant MeSH Terms

Gram-positive Bacterial Infections