Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients (NCT03873987) | Clinical Trial Compass
CompletedPhase 1
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
United States102 participantsStarted 2019-07-16
Plain-language 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 (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin
Who can participate
Age range18 Years
SexALL
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Inclusion 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
✕. 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).
What they're measuring
1
Relative Exposure of AUC of the New Formulation to the Approved Formulation
Timeframe: 72 hours
2
Relative Exposure of AUC of the New Formulation to the Approved Formulation
. 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).