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Evaluating a single-dose IV treatment for skin infections in children

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

Phase 2 Interventional Melinta Therapeutics, Inc. · NCT05599295

This study tests if a single-dose IV treatment called oritavancin is safe and works better than regular antibiotics for children with skin infections.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages3 Months to 17 Years
SexAll
SponsorMelinta Therapeutics, Inc. Industry-sponsored
Locations29 sites (Tampa, Florida and 28 other locations)
Trial IDNCT05599295 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of a single-dose intravenous treatment with oritavancin compared to standard antibiotics for pediatric patients with acute bacterial skin and skin structure infections (ABSSSIs). It is a randomized, open-label study that includes pharmacokinetic sampling and clinical outcome assessments to gather data while minimizing the burden on participants and their caregivers. The study specifically looks at two formulations of oritavancin, ORBACTIV and KIMYRSA, to provide detailed product-specific information.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 months to under 18 years diagnosed with acute bacterial skin and skin structure infections caused by gram-positive pathogens.

Not a fit: Patients with skin infections not caused by gram-positive pathogens or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and convenient option for managing serious skin infections in children.

How similar studies have performed: Other studies have shown promise with similar antibiotic treatments, but this specific approach with oritavancin is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female, 3 months to \<18 years of age at randomization
2. Diagnosis of at least one 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 two of the following signs and symptoms:

   1. Purulent drainage or discharge
   2. Erythema (\>1 cm 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 one of the following signs of systemic inflammation:

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   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/mm3) or increased WBC (\>12,000mm3)
   5. Bandemia \>10%
   6. C-reactive protein (CRP) \>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:

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

   1. Infection suspected or documented to be caused solely by gram-negative pathogens (e.g., 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 (e.g., septic arthritis, endocarditis, osteomyelitis).
   4. Infected burn
   5. Primary infection superimposed on a pre-existing skin disease with associated inflammatory changes, e.g., atopic dermatitis, eczema
   6. Any evolving necrotizing process (e.g., necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by clostridioides species (e.g., 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 (e.g., influenza, COVID-19) which, in the Investigator's judgement, will impact the study clinical outcome assessments (e.g., subject is febrile due to the viral infection)
8. Subjects currently receiving chronic systemic immunosuppressive therapy
9. Subjects with neutropenia, defined as absolute neutrophil count (ANC) \<500 cells/mm3
10. Creatinine clearance (CrCl) \< 30 mL/min/1.73 m2 as calculated using the updated Schwartz bedside formula:

    eGFR = k x (height in cm) ÷ serum Creatinine k = 0.33 in pre-term infants. k = 0.45 in term infants to 1 year of age. k = 0.55 in children and adolescent girls. k = 0.70 in adolescent boys
11. Menstruating females with a positive result for the urine or serum human chorionic gonadotropin (HCG) test administered at screening
12. Females of childbearing potential (and males with female partners of childbearing potential) unwilling to practice abstinence or use at least two methods of contraception (e.g., oral contraceptives, barrier methods, approved contraceptive implants) during the entire study period
13. Subjects with a history of infusion-related immunoglobulin E (IgE)-mediated allergic reaction or hypersensitivity reaction to glycopeptides (e.g., vancomycin, telavancin, dalbavancin, oritavancin, teicoplanin) or any of their excipients
14. Subjects who are taking heparin (other than heparin flush for line patency) or warfarin, and/or require anticoagulant monitoring \[activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR)\]
15. Subjects receiving treatment with an investigational medicinal product or investigational device within 3 months before enrollment or during the study
16. Subjects whom the investigator considers unlikely to adhere to the protocol, comply with Study Drug administration, or complete the clinical study (e.g., unlikely to survive 28 days from initiation of Study Drug)
17. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3x ULN or total bilirubin ≥2x ULN.

Where this trial is running

Tampa, Florida and 28 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Bacterial Skin and Skin Structure Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.