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Glycopeptide Antibiotic
Oritavancin for Skin Infections
Phase 2
Recruiting
Research Sponsored by Melinta Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of at least one of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen): Wound infection, Cellulitis/erysipelas, Major cutaneous abscess
ABSSSI must present with at least two of the specified signs and symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up eot day 14; toc day 28
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of two versions of oritavancin, a drug used to treat skin infections, in pediatric patients versus standard of care antibiotics.
Who is the study for?
This trial is for children aged 3 months to under 18 years with certain bacterial skin infections. They must have symptoms like wound infection, cellulitis, or abscesses caused by gram-positive bacteria. Kids can't join if they've had extensive prior antibiotic treatment, severe kidney issues, allergic reactions to similar drugs, are on blood thinners or immunosuppressants, or have certain viral infections.Check my eligibility
What is being tested?
The study tests the safety of a single IV dose of Oritavancin (found in ORBACTIV and KIMYRSA) against standard antibiotics for treating pediatric acute bacterial skin infections. It's an open-label study that includes pharmacokinetic sampling and clinical outcome assessments.See study design
What are the potential side effects?
While specific side effects aren't listed here, Oritavancin may cause typical antibiotic-related side effects such as digestive discomforts (nausea/vomiting), potential allergic reactions, liver enzyme elevations which indicate stress on the liver, and possibly affect blood clotting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a serious skin infection like a wound, cellulitis, or a large abscess.
Select...
I have at least two symptoms of a severe skin infection.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ eot day 14; toc day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eot day 14; toc day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Assessments
Secondary outcome measures
Clinical Outcome Assessments
Test of Cure
Side effects data
From 2016 Phase 4 trial • 17 Patients • NCT024529187%
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
3Treatment groups
Experimental Treatment
Active Control
Group I: OrbactivExperimental Treatment1 Intervention
ORBACTIV is infused at 15mg/kg over 3 hours for all subjects not to exceed a dose of 1200mg.
Group II: KimyrsaExperimental Treatment1 Intervention
KIMYRSA is infused at 15mg/kg over 1 hour for subjects ≥12 years old and weighing >40 kg not to exceed a dose of 1200mg.
KIMYRSA is infused at 15mg/kg over 3 hours in subjects <12 years old or weighing ≤40 kg.
Group III: Standard of CareActive Control1 Intervention
The following SoC medications below will be administered via IV infusion, per the package insert, and according to local rules and regulations. SoC medications cannot be used in combination with one another.
Vancomycin
Teicoplanin
Clindamycin
Daptomycin
Semi-synthetic penicillins (e.g., nafcillin, oxacillin, cloxacillin)
Cefazolin
Ceftaroline
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, Inc.Lead Sponsor
33 Previous Clinical Trials
9,277 Total Patients Enrolled
1 Trials studying Skin Infections
150 Patients Enrolled for Skin Infections
Melinta Therapeutics, LLCLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to use two forms of birth control or practice abstinence during the study.I have been treated with antibiotics for a skin infection for more than 72 hours.I have taken a glycopeptide antibiotic within the last 24 hours.I have a serious skin infection like a wound, cellulitis, or a large abscess.I have at least two symptoms of a severe skin infection.I have not used any experimental drugs or devices in the last 3 months.I am under 18 years old.Your liver function tests show high levels of ALT, AST, or bilirubin.I do not have a serious viral infection like the flu or COVID-19.You have an infection that may be related to a medical device or implant.You have septic shock or unstable blood pressure.I am a woman still having periods and my pregnancy test was positive.Your kidneys are not working well, as calculated by a special formula.I am on blood thinners like heparin or warfarin and need regular monitoring.You have had a serious allergic reaction to glycopeptides or any of their ingredients in the past.I have a skin infection related to a specific condition.I am on long-term medication to suppress my immune system.I have a low white blood cell count.
Research Study Groups:
This trial has the following groups:- Group 1: Orbactiv
- Group 2: Kimyrsa
- Group 3: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I potentially sign up for participation in this medical experiment?
"This trial is seeking 200 children aged 3 Months to 17 with acute bacterial skin and skin structure infection (ABSSSI). Eligible participants must meet the following descriptors: gender, age range, type of wound infection (traumatic or surgical), presence of cellulitis/erysipelas, major cutaneous abscesses, purulent drainage or discharge from the infected area, erythema (>1 cm beyond edge of wound or abscess), fluctuance in affected areas, heat/warmth on site of infection, edema/induration in surrounding regions as well as lymph node swelling and tenderness."
Answered by AI
Is the study open to applicants beyond 75 years of age?
"This study is offering participation to candidates between 3 Months and 17 years of age."
Answered by AI
Has the Food and Drug Administration sanctioned Kimyrsa for clinical use?
"Kimysra has been rated a 2 on the safety scale due to evidence-based data indicating its security, though there is yet no proof of efficacy."
Answered by AI
Is recruitment open for this investigation?
"This investigation, as evidenced by the info hosted on clinicaltrials.gov, is not presently accepting patients. It was initially posted on October 31st 2022 and last updated five days later at the end of October. Unfortunately this trial does not need additional participants right now; however there are 769 other trials that do require volunteers currently enlisting applicants."
Answered by AI
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