Acute Bacterial Skin and Skin Structure Infections
Conditions
Interventions
Trade Name: ORBACTIV®
Product Name: ORBACTIV®
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Oritavancin
CAS Number: 171099-57-3
Concentration unit: mg/kg milligram(s
Sponsors
Melinta Therapeutics, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 3 months to 1 cm beyond edge of wound or abscess) c. Fluctuance d. Heat or localized warmth e. Edema/induration f. Pain or tenderness to palpation AND at least one of the following signs of systemic inflammation: a. Proximal lymph node swelling and tenderness b. Increased temperature (>38.0°C [>100.4°F]) c. Decreased temperature (12,000mm3) e. Bandemia >10% f. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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: a. Infection suspected or documented to be caused solely by gramnegative pathogens (e.g., human or animal bite, injury contaminated with fresh or saltwater, external malignant otitis), fungi, or viruses b. Wound infection (surgical or traumatic) or abscess with only gram-negative pathogens c. Concomitant infection at another body site, from bacteria that is different from gram-positive bacteria causing the ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis). Secondary infections due to the same gram-positive bacteria are eligible to be enrolled in this study. d. Infected burn e. Primary infection superimposed on a pre-existing skin disease with associated inflammatory changes, e.g., atopic dermatitis, eczema f. 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) g. 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 ab-solute neutrophil count (ANC) <500 cells/mm3 10. Subjects with severe renal impairment as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 when using the updated bedside Schwartz formula. For subjects 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/dL, from Table 10 OR requirement for dialysis. Subjects under 1 year of age with renal impairment require, consultation with the Sponsor Medical Monitor before enrollment (see Appendix 3). 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, from the time of 1st dose until 50 days after the last dose of protocol- defined study medication. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of single-dose IV oritavancin (ORBACTIV and KIMYRSA) relative to Standard of Care (SoC) treatments in pediatric subjects with Acute ABSSSI.;Secondary Objective: To evaluate the Clinical Response of single-dose IV oritavancin (ORBACTIV and KIMYRSA) relative to SoC treatments in pediatric subjects with ABSSSI To evaluate the pharmacokinetic (PK) profile of single-dose IV oritavancin (ORBACTIV and KIMYRSA) in pediatric subjects with ABSSSI;Primary end point(s): Safety assessment of ORBACTIV and KIMYRSA in pediatric populations.;Timepoint(s) of evaluation of this end point: Data will be analyzed by treatment group using the following parameters: laboratory results, vital signs, adverse events (AEs), physical examinations, and concomitant medication use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All-cause mortality assessed at the Time of Cure (ToC) visit ;Timepoint(s) of evaluation of this end point: o Clinical Response of Cure, Failure, or Unknown at EoT Visit o Clinical Response of Cure, Failure, or Unknown at ToC Visit | — |
Countries
Belgium, Bulgaria, Greece, Latvia, Lithuania, Poland, Portugal, Romania, Spain, United States
Contacts
Public ContactDouglas Girgenti
Melinta Therapeutics, LLC
Outcome results
None listed