Acute Bacterial Skin and Skin Structure Infections (ABSSSI) MedDRA version: 20.1 Level: PT Classification code 10052891 Term: Skin bacterial infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Sivextro
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TEDIZOLID PHOSPHATE
CAS Number: 856867-55-5
Current Sponsor code: MK-1986
Other descript
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have a parent/legally acceptable representative (LAR) who is able to give documented informed consent and willing and able to comply with all required study procedures . Assent is required of subjects who in the investigator's judgment are capable of understanding the nature of the study. 2. Be male or female from birth to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has an uncomplicated skin and skin structure infection such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound -associated foreign body reactions (e.g., stitch abscesses) 2. Has ABSSSI due to or associated with any of the conditions listed in the protocol 3. Has received antibacterial therapy for treatment of the current episode of ABSSSI unless: • = 48 hours of effective antibacterial drug therapy with a short-acting antibacterial drug (defined as administration frequency of 1 or more doses per 24 hours) OR • Response to prior antibacterial therapy for the primary infection site of ABSSSI is considered by the investigator to be failure (no improvement in signs and symptoms [e.g., fever, pain, tenderness, lesion size increase]) after at least 48 hours of therapy 4. Has known bacteremia, severe sepsis, or septic shock at the Screening Visit 5. Has significant or life-threatening condition, disease, or organ system condition (e.g., endocarditis, meningitis) 6. Has recent history of opportunistic infections where the underlying cause of these infections is still active (e.g., leukemia, transplant, acquired immunodeficiency syndrome), or is suspected to be at risk of opportunistic infections or infection with unusual pathogens (e.g., primary immune deficiency, cystic fibrosis) 7. Has received or is receiving treatment for active tuberculosis (within 1 month) 8. Has known or suspected severe neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) 9. Is human immunodeficiency virus (HIV) positive and has known or suspected CD4 cell count < 15% 10. Has renal impairment that requires peritoneal dialysis, plasmapheresis, hemodialysis, venovenous dialysis, or other forms of renal filtration 11. Has known or suspected severe hepatic impairment 12. Has cardiac or ECG finding which in the opinion of the investigator would limit the subject's ability to complete and/or participate in this clinical study. For neonates, an ECG is not required, but ECG data will be collected if available. 13. Has received investigational medicinal product within 30 days before the first administration of study drug. (Investigational product in this case refers to a product that is not approved in the country in which the subject is enrolled, for either adults or children, for any indication.) 14. Has an investigational device present or removed within 30 days before the first administration of study drug or presence of devicerelated infection 15. Was previously treated in tedizolid phosphate clinical studies (including this protocol) 16. Has contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation 17.Has contraindication, including hypersensitivity to all available comparator drugs. 18.Has a wound infection, and meets either of the conditions listed in the protocol 19.Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the EOT Visit, is allowed, as is administration during treatment with IV study drug). 20. Is a female who is pregnant or nursing, or who is of childbearing potential and not abstinent or a male who is not abstinent 21. Has circumstances, including those of parent(s)/legal guardian(s), that make adherence to the protocol, comp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) The primary objective is to use descriptive statistics to evaluate the safety of intravenous (IV) and/or oral 6- or 10-day tedizolid phosphate with 10- or 14-day IV and/or oral comparator in subjects 3 months to <12 years of age with acute bacterial skin and skin structure infections (ABSSSI). No formal hypothesis tests will be used to evaluate this endpoint.;Secondary Objective: (1) To use descriptive statistics to evaluate investigator’s assessment of clinical response in the tedizolid phosphate and comparator groups at the test-of-cure (TOC) visit on Day 25 in the intention to treat (ITT) and clinically evaluable at TOC (CE-TOC) populations.;Primary end point(s): The primary endpoint is the overall safety assessment of tedizolid phosphate within the pediatric population. Multiple assessments are conducted to evaluate the safety: 1. Adverse events; 2. Vital signs; 3. Physical exams including specific neurological and visual acuity assessments; 4. Hematology and clinical chemistry.;Timepoint(s) of evaluation of this end point: At each scheduled visits until the Late follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The investigator's assessment of clinical response at the TOC visit, 22-29 days after the first infusion, in the Intent to Treat (ITT) and Clinically Evaluable at Test of Cure (CE-TOC) populations;;Timepoint(s) of evaluation of this end point: At TOC (Test of Cure) which is about 22-29 days after the first dose. | — |
Countries
Brazil, Georgia, Guatemala, Mexico, Russian Federation, South Africa, Türkiye, Ukraine, United States
Contacts
Public ContactPamela Suzanne Sears
Merck Sharp & Dohme LLC
Outcome results
None listed