Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections

NCT05599295 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: ML-ORI-2012024-516385-10-00
• Study Type: interventional
• Target: 118
• Locations: 8 countries
• Sites: 23

Brief Summary

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric participants with acute bacterial skin and skin structure infections (ABSSSIs). This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both). The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.

Conditions

Acute Bacterial Skin and Skin Structure Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  Day 1 through Day 28

Secondary Outcomes (4)

• All-cause Mortality

  Day 28

• Number of Participants with a Clinical Response of Cure or Failure

  Day 14 and Day 28

• Area Under the Curve of Plasma Concentration (AUC) of Oritavancin

  Day 1 (up to 168 hours after start of infusion)

• Maximal Plasma Concentration (Cmax) of Oritavancin

  Day 1 (up to 168 hours after start of infusion)

Study Arms (2)

Orbactiv

EXPERIMENTAL

Orbactiv will be infused at 15 milligrams/kilogram (mg/kg) over 3 hours for all participants and will not exceed a dose of 1200 mg.

Drug: Orbactiv

Kimyrsa

EXPERIMENTAL

Kimyrsa will be infused at 15 mg/kg over 3 hours for all participants and will not exceed a dose of 1200 mg.

Drug: Kimyrsa

Interventions

Orbactiv DRUG

Solution for IV infusion

Also known as: Oritavancin

Orbactiv

Kimyrsa DRUG

Solution for IV infusion

Also known as: Oritavancin

Kimyrsa

Eligibility Criteria

• Age: 3 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, 3 months to \<12 years of age at randomization
• Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen):
• Wound infection: that is either traumatic or surgical in origin, defined as an infection characterized by purulent drainage from a wound with surrounding erythema, edema, and/or induration
• Cellulitis/erysipelas: a diffuse skin infection characterized by spreading areas of erythema, edema, and/or induration
• Major cutaneous abscess: an infection characterized by a collection of pus within the dermis or subcutaneous tissue that is accompanied by surrounding erythema, edema, and/or induration
• ABSSSI must present with at least 2 of the following signs and symptoms:
• Purulent drainage or discharge
• Erythema (\>1 centimeter beyond edge of wound or abscess)
• Fluctuance
• Heat or localized warmth
• Edema/induration
• Pain or tenderness to palpation
• and at least 1 of the following signs of systemic inflammation:
• Proximal lymph node swelling and tenderness
• Increased temperature (\>38.0°C \[\>100.4°F\])

You may not qualify if:

• Participants who have received more than 72 hours of effective antibacterial drug therapy for treatment of the current episode of ABSSSI
• Participants who have received a glycopeptide antibiotic (for example, vancomycin, telavancin, teicoplanin) within 24 hours of randomization
• Participants who have received dalbavancin within 45 days prior to randomization
• Participants who have been treated with oritavancin within the last 50 days
• Participants with infection suspected to be associated with a device or implant
• Participants with septic shock or hemodynamic instability
• Participants with ABSSSI due to, or associated with any of the following:
• Infection suspected or documented to be caused predominantly by gram-negative pathogens (for example, human or animal bite, injury contaminated with fresh or saltwater, external malignant otitis), fungi, or viruses
• Wound infection (surgical or traumatic) or abscess with only gram-negative pathogens
• Concomitant infection at another site, not including a secondary ABSSSI lesion (for example, septic arthritis, endocarditis, osteomyelitis). Secondary infections due to the same gram-positive bacteria are eligible to be enrolled in this study.
• Infected burn
• Primary infection superimposed on a pre-existing skin disease with associated inflammatory changes (for example, atopic dermatitis, eczema)
• Any evolving necrotizing process (for example, necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by clostridioides species (for example, crepitance on examination of the ABSSSI site and/or surrounding tissue\[s\], radiographic evidence of subcutaneous gas in proximity to the infection)
• Clinically significant viral infection (for example, influenza, Coronavirus Disease 2019) which, in the investigator's judgement, will impact the study clinical outcome assessments (for example, participant is febrile due to the viral infection)
• Participants currently receiving chronic systemic immunosuppressive therapy

Sponsors & Collaborators

• Melinta Therapeutics, LLC: lead

Study Sites (23)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205-2664, United States

Location

Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD

Lom, Montana, 3600, Bulgaria

Location

Multiprofile Hospital For Active Treatment Dr Tota Venkova

Gabrovo, 5300, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd

Plovdiv, 4000, Bulgaria

Location

University Multiprofile Hospital For Active Treatment Kanev AD

Rousse, 7002, Bulgaria

Location

University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

Sofia, 1606, Bulgaria

Location

University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD

Stara Zagora, 6003, Bulgaria

Location

Attikon University General Hospital

Chaïdári, Attica, 124 62, Greece

Location

Hippokratio General Hospital of Thessaloniki

Thessaloniki, 546 42, Greece

Location

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 56429, Greece

Location

Daugavpils Regional Hospital

Daugavpils, Daugavpils Aprinkis, LV-5417, Latvia

Location

Children's Clinical University Hospital

Riga, LV-1004, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Kaunas County, LT-50009, Lithuania

Location

Klaipeda Children Hospital

Klaipėda, Klaipėda County, 92140, Lithuania

Location

Hospital de Cascais

Alcabideche, Lisbon District, 2755-009, Portugal

Location

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital São Francisco Xavier

Lisbon, 1449-005, Portugal

Location

Louis Turcanu Emergency Clinical Hospital for Children

Timișoara, Timiș County, 300011, Romania

Location

Brasov Children Clinical Hospital

Brasov, 500063, Romania

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8035, Spain

Location

Hospital Sant Joan de Deu - PIN

Barcelona, 8950, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

MeSH Terms

Interventions

oritavancin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 31, 2022
• Study Start: June 15, 2023
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (2); PT (2); LA (2); GR (3); LI (2); BU (6); RO (2); ES (4)