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CompletedNCT05599295Updated Nov 25, 2025

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

A Phase 2 interventional study of Orbactiv and Kimyrsa in Acute Bacterial Skin and Skin Structure Infection, sponsored by Melinta Therapeutics, LLC. Completed at 23 sites in 8 countries. Open to participants aged 3 Months to 11 Years. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Melinta Therapeutics, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
3 Months to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Bacterial Skin and Skin Structure Infection
03

In context

Lead sponsor

Melinta Therapeutics, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, 3 months to \<12 years of age at randomization
  2. Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen):

    1. 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
    2. Cellulitis/erysipelas: a diffuse skin infection characterized by spreading areas of erythema, edema, and/or induration
    3. 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
  3. ABSSSI must present with at least 2 of the following signs and symptoms:

    1. Purulent drainage or discharge
    2. Erythema (>1 centimeter beyond edge of wound or abscess)
    3. Fluctuance
    4. Heat or localized warmth
    5. Edema/induration
    6. Pain or tenderness to palpation

    and at least 1 of the following signs of systemic inflammation:

    1. Proximal lymph node swelling and tenderness
    2. Increased temperature (>38.0°C [>100.4°F])
    3. Decreased temperature (\<36.0°C [\<96.8°F])
    4. Decreased white blood count (WBC) (\<4000/cubic millimeter [mm\^3]) or increased WBC (>12,000 mm\^3)
    5. Bandemia >10%
    6. C-reactive protein >upper limit of normal (ULN)
  4. Written informed consent obtained from parent(s) or legal guardian(s), with written or documented verbal assent of the child obtained, when appropriate, before initiation of any assessments conducted solely for study purposes

Exclusion criteria

Exclusion Criteria:

  1. Participants who have received more than 72 hours of effective antibacterial drug therapy for treatment of the current episode of ABSSSI
  2. Participants who have received a glycopeptide antibiotic (for example, vancomycin, telavancin, teicoplanin) within 24 hours of randomization
  3. Participants who have received dalbavancin within 45 days prior to randomization
  4. Participants who have been treated with oritavancin within the last 50 days
  5. Participants with infection suspected to be associated with a device or implant
  6. Participants with septic shock or hemodynamic instability
  7. Participants with ABSSSI due to, or associated with any of the following:

    1. 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
    2. Wound infection (surgical or traumatic) or abscess with only gram-negative pathogens
    3. 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.
    4. Infected burn
    5. Primary infection superimposed on a pre-existing skin disease with associated inflammatory changes (for example, atopic dermatitis, eczema)
    6. 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)
    7. 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)
  8. Participants currently receiving chronic systemic immunosuppressive therapy
  9. Participants with neutropenia, defined as absolute neutrophil count \<500 cells/mm\^3
  10. Participants with severe renal impairment, defined as an estimated glomerular filtration rate \<30 milliliters/minute/1.73 meters squared, using the updated bedside Schwartz formula. For participants under 1 year of age, severe renal impairment is defined as serum creatinine ≥2 times the 97.5th percentile creatinine for age, converted to mg/deciliter or a requirement for dialysis. Participants under 1 year of age with renal impairment require consultation with the sponsor's medical monitor before enrollment.
  11. Menstruating females with a positive result for the urine or serum human chorionic gonadotropin test administered at screening
  12. Females of childbearing potential (and males with female partners of childbearing potential) unwilling to practice abstinence or use highly effective methods of contraception during the entire study period from the time of the first dose and until 50 days after the last dose of protocol-defined study medication. A list of acceptable methods of contraception is listed in the protocol.
  13. Participants with a history of infusion-related immunoglobulin E-mediated allergic reaction or hypersensitivity reaction to glycopeptides (for example, vancomycin, telavancin, dalbavancin, oritavancin, teicoplanin) or any of their excipients
  14. Participants who are taking heparin (other than heparin flush for line patency) or warfarin, and/or require anticoagulant monitoring (activated partial thromboplastin time, prothrombin time, international normalized ratio)
  15. Participants receiving treatment with an investigational medicinal product or investigational device within 3 months before enrollment or during the study
  16. Participants whom the investigator considers unlikely to adhere to the protocol, comply with investigational medicinal product (IMP) administration, or complete the clinical study (for example, unlikely to survive 28 days from initiation of IMP)
  17. Participants with alanine aminotransferase or aspartate aminotransferase >3* ULN or total bilirubin ≥2* ULN
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    Orbactiv

    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

  • Experimental
    Kimyrsa

    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

  • DrugOrbactiv

    Solution for IV infusion

    Also known as: Oritavancin

  • DrugKimyrsa

    Solution for IV infusion

    Also known as: Oritavancin

06

What researchers measure

Primary outcomes

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

    Time frame: Day 1 through Day 28

Secondary outcomes

  1. All-cause Mortality

    Time frame: Day 28

  2. Number of Participants with a Clinical Response of Cure or Failure

    Time frame: Day 14 and Day 28

  3. Area Under the Curve of Plasma Concentration (AUC) of Oritavancin

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

  4. Maximal Plasma Concentration (Cmax) of Oritavancin

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

07

Study locations

23 sites
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205-2664, United States
  • Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
    Lom, Montana 3600, Bulgaria
  • Multiprofile Hospital For Active Treatment Dr Tota Venkova
    Gabrovo, 5300, Bulgaria
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd
    Plovdiv, 4000, Bulgaria
  • University Multiprofile Hospital For Active Treatment Kanev AD
    Rousse, 7002, Bulgaria
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
    Sofia, 1606, Bulgaria
  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
    Stara Zagora, 6003, Bulgaria
  • Attikon University General Hospital
    Chaïdári, Attica 124 62, Greece
  • Hippokratio General Hospital of Thessaloniki
    Thessaloniki, 546 42, Greece
  • Papageorgiou General Hospital of Thessaloniki
    Thessaloniki, 56429, Greece
  • Daugavpils Regional Hospital
    Daugavpils, Daugavpils Aprinkis LV-5417, Latvia
  • Children's Clinical University Hospital
    Riga, LV-1004, Latvia
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos
    Kaunas, Kaunas County LT-50009, Lithuania
  • Klaipeda Children Hospital
    Klaipėda, Klaipėda County 92140, Lithuania
  • Hospital de Cascais
    Alcabideche, Lisbon District 2755-009, Portugal
  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital São Francisco Xavier
    Lisbon, 1449-005, Portugal
  • Louis Turcanu Emergency Clinical Hospital for Children
    Timișoara, Timiș County 300011, Romania
  • Brasov Children Clinical Hospital
    Brasov, 500063, Romania
  • Hospital Universitario Vall d'Hebron - PPDS
    Barcelona, 8035, Spain
  • Hospital Sant Joan de Deu - PIN
    Barcelona, 8950, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Hospital Universitario La Paz - PPDS
    Madrid, 28046, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05599295
Lead sponsor
Melinta Therapeutics, LLC
Responsible party
Sponsor
First posted
Oct 31, 2022
Start date
Jun 15, 2023
Primary completion
Nov 20, 2025
Completion
Nov 20, 2025
Last update
Nov 25, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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