Status:
COMPLETED
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
Lead Sponsor:
Melinta Therapeutics, Inc.
Conditions:
Acute Bacterial Skin and Skin Structure Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection ...
Detailed Description
Single IV dose oritavancin (1200 mg) has been approved in the U.S. for the treatment of adult patients with ABSSSI caused or suspected to be caused by Gram-positive microorganisms. The current study i...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects may be included in the study if they meet all of the following criteria:
- Subject must be 18 years of age or older, male or female, and of any race.
- Subject must give written informed consent before initiation of any study-related procedures.
- Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy.
- If female, the subject is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use at least 2 highly effective methods of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, abstinence) for the duration of the study until 60 days after study drug administration, or male partner sterilization alone.
- Subject must express a commitment to comply with all study visits, procedures and requirements for the duration of the study.
- Exclusion Criteria
- Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- Infections associated with, or in close proximity to, a prosthetic device.
- Severe sepsis or refractory shock.
- Known or suspected bacteremia at time of screening.
- ABSSSI due to or associated with any of the following:
- Infections suspected or documented to be caused by only Gram-negative pathogens (i.e., infections acquired during prolonged admission in hospital or long-term care facilities).
- Diabetic foot infections (infection extending distal to the malleoli in a subject with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot).
- Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis).
- Infected burns.
- A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa.
- Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous).
- Any evolving necrotizing process (i.e., necrotizing fasciitis), gangrene or infection suspected or proven to be caused by Clostridium species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection).
- Infections known to be caused by an organism resistant to oritavancin.
- Catheter site infections.
- Treatment with investigational medicinal product within 30 days or 5 half-lives, whichever is longer, before enrollment and for the duration of the study.
- Subjects currently receiving anticoagulant therapy.
- Known liver function tests (LFTs) ≥ 3 times the upper limit of normal (ULN) or total bilirubin ≥ 2 times ULN.
- Any medical condition, which in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug.
- Any planned, major surgical procedure during the study period (Day 15).
- Subject is the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- Known hypersensitivity to oritavancin, glycopeptides or HPβCD.
- Female subject who has a positive pregnancy test or is breastfeeding.
- Previous use of oritavancin or anticipated need to use a long acting glycopeptide during the study.
Exclusion
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03873987
Start Date
July 16 2019
End Date
September 4 2019
Last Update
April 13 2021
Active Locations (4)
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1
ML-ORI-102 Study Site
Chula Vista, California, United States, 91911
2
ML-ORI-102 Study Site
La Mesa, California, United States, 91942
3
ML-ORI-102 Study Site
Burr Ridge, Illinois, United States, 60527
4
ML-ORI-102 Study Site
Somers Point, New Jersey, United States, 08244