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Glycopeptide Antibiotic

Oritavancin for Bacterial Infections in Children

Phase 1
Recruiting
Research Sponsored by Melinta Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females <18 years of age
Suspected or diagnosed Gram positive bacterial infection for which the subject is receiving standard antibiotic therapy; or peri-operative prophylactic use of antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 336 hours post infusion start time for cohorts 1-4 and 168 hours for cohort 5
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in children with a bacterial infection.

Who is the study for?
This trial is for children under 18 with suspected or confirmed Gram-positive bacterial infections. Neonates must be at least 34 weeks post-conception age. Participants need IV access and will stay in the hospital for observation after receiving the drug. Those with septic shock, hypersensitivity to similar drugs, recent use of certain antibiotics, or females who are pregnant/lactating or not using contraception are excluded.Check my eligibility
What is being tested?
The study tests Oritavancin's effects on pediatric patients with bacterial infections. It aims to understand how the body processes this drug (pharmacokinetics), its safety, and tolerability when given to kids and teenagers as either a treatment for infection or as a preventive measure during surgery.See study design
What are the potential side effects?
While specific side effects in children aren't detailed here, Oritavancin may cause symptoms like allergic reactions, gastrointestinal issues (nausea/vomiting), skin reactions at injection site, liver enzyme changes, blood clotting problems and possibly others similar to adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 years old.
Select...
I am currently being treated with antibiotics for a suspected or confirmed Gram positive bacterial infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~336 hours post infusion start time for cohorts 1-4 and 168 hours for cohort 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and 336 hours post infusion start time for cohorts 1-4 and 168 hours for cohort 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic Parameter (Area under the plasma concentration time-curve [AUC])
Secondary outcome measures
Pharmacokinetic Parameters
Safety Endpoint

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02452918
7%
Infusion site phlebitis
7%
Subcutaneous hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oritavancin 1200 mg Without Concomitant Warfarin Therapy
Oritavancin 1200 mg With Concomitant Warfarin Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: OritavancinExperimental Treatment1 Intervention
Single-Dose IV Oritavancin Diphosphate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oritavancin
2015
Completed Phase 4
~460

Find a Location

Who is running the clinical trial?

Melinta Therapeutics, LLCLead Sponsor
2 Previous Clinical Trials
208 Total Patients Enrolled
Melinta Therapeutics, Inc.Lead Sponsor
33 Previous Clinical Trials
9,425 Total Patients Enrolled
Karen FusaroStudy DirectorMelinta Therapeutics, Inc.
4 Previous Clinical Trials
906 Total Patients Enrolled

Media Library

Oritavancin (Glycopeptide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02134301 — Phase 1
Gram Positive Bacterial Infection Research Study Groups: Oritavancin
Gram Positive Bacterial Infection Clinical Trial 2023: Oritavancin Highlights & Side Effects. Trial Name: NCT02134301 — Phase 1
Oritavancin (Glycopeptide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02134301 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections
2014. "Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02134301.
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