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Acute Bacterial Skin and Skin Structure InfectionPhase 2NCT05599295

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

A Phase 2 study testing Orbactiv and Kimyrsa in people with Acute Bacterial Skin and Skin Structure Infection, run by Melinta Therapeutics, LLC at 23 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 months to 11 years
What is being tested?
Orbactiv and Kimyrsa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
23 sitesin 8 countries
Study dates
15 Jun 2023to 20 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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:
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  • 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])
  • Decreased temperature (<36.0°C [<96.8°F])
  • Decreased white blood count (WBC) (<4000/cubic millimeter [mm^3]) or increased WBC (>12,000 mm^3)
  • Bandemia >10%
  • C-reactive protein >upper limit of normal (ULN)
  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • Participants with neutropenia, defined as absolute neutrophil count <500 cells/mm^3
  • 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.
  • Menstruating females with a positive result for the urine or serum human chorionic gonadotropin test administered at screening
  • 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.
  • 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
  • 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)
  • Participants receiving treatment with an investigational medicinal product or investigational device within 3 months before enrollment or during the study
  • 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)
  • Participants with alanine aminotransferase or aspartate aminotransferase >3* ULN or total bilirubin ≥2* ULN

Trial locations and contacts

23 sites in 8 countries.

23 sites in 8 countries

Bulgaria6 sites

  • Multiprofile Hospital For Active Treatment Dr Tota Venkova

    Gabrovo, 5300

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

    Lom, Montana, 3600

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

    Plovdiv, 4000

  • University Multiprofile Hospital For Active Treatment Kanev AD

    Rousse, 7002

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

    Sofia, 1606

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

    Stara Zagora, 6003

Other trials in Bulgaria

Spain4 sites

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035

  • Hospital Sant Joan de Deu - PIN

    Barcelona, 8950

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

Other trials in Spain

Greece3 sites

  • Attikon University General Hospital

    Chaïdári, Attica, 124 62

  • Hippokratio General Hospital of Thessaloniki

    Thessaloniki, 546 42

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56429

Other trials in Greece

United States2 sites

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205-2664

  • Tampa General Hospital

    Tampa, Florida, 33606

Other trials in United States

Latvia2 sites

  • Daugavpils Regional Hospital

    Daugavpils, Daugavpils Aprinkis, LV-5417

  • Children's Clinical University Hospital

    Riga, LV-1004

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, Kaunas County, LT-50009

  • Klaipeda Children Hospital

    Klaipėda, Klaipėda County, 92140

Other trials in Lithuania

Portugal2 sites

  • Hospital de Cascais

    Alcabideche, Lisbon District, 2755-009

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

    Lisbon, 1449-005

Other trials in Portugal

Romania2 sites

  • Brasov Children Clinical Hospital

    Brasov, 500063

  • Louis Turcanu Emergency Clinical Hospital for Children

    Timișoara, Timiș County, 300011

Other trials in Romania

About this study

Official title: A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous Oritavancin for the Treatment of Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

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.

Being tested
Orbactiv, Kimyrsa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrbactivDrug

    Also called Oritavancin

    Solution for IV infusion

  • KimyrsaDrug

    Also called Oritavancin

    Solution for IV infusion

Study groups in NCT05599295
Study groupRoleWhat they receive
OrbactivExperimentalOrbactiv will be infused at 15 milligrams/kilogram (mg/kg) over 3 hours for all participants and will not exceed a dose of 1200 mg.
Receives: Drug: Orbactiv
KimyrsaExperimentalKimyrsa will be infused at 15 mg/kg over 3 hours for all participants and will not exceed a dose of 1200 mg.
Receives: Drug: Kimyrsa

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 through Day 28

Secondary outcomes (4)

  1. All-cause Mortality

    Measured: Day 28

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

    Measured: Day 14 and Day 28

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

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

  4. Maximal Plasma Concentration (Cmax) of Oritavancin

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start15 Jun 2023
  3. Primary completion20 Nov 2025
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599295
Sponsor's protocol ID
ML-ORI-201
Other IDs
2024-516385-10-00
Status last verified
Nov 2025
First submitted
20 Oct 2022
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orbactiv and Kimyrsa in people with Acute Bacterial Skin and Skin Structure Infection, run by Melinta Therapeutics, LLC at 23 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Bulgaria, Spain, Greece, United States, Latvia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 through Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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