Study of Tedizolid Phosphate in Adolescents With cSSTI
- Conditions
- complicated skin and soft tissue infection (cSSTI)MedDRA version: 20.1Level: HLTClassification code 10040786Term: Skin structures and soft tissue infectionsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-004023-40-PL
- Lead Sponsor
- Cubist Pharmaceuticals LLC, an indirect wholly-owned subsidiary of Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
•Males or females 12 years to <18 years
•Adequate venous access for IV administration of study drug for at least 24 hours (for those subjects receiving IV study medication) and for collection of protocol-specified blood samples.
•Local symptoms must have started within 7 days before Study Day -1
•cSSTI meeting at least 1 of the clinical syndrome definitions.
•Suspected or documented Gram-positive infection from baseline Gram stain or culture.
•Parent/LAR able to give informed consent and willing and able to comply with all required study procedures. Assent is also required of children who in the Investigator's judgment are capable of understanding the nature of the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 162
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
•Uncomplicated minor skin and skin structure infections such as pustules, folliculitis, furuncles, minor abscesses (small volume of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound associated foreign body reactions (eg, stitch abscesses)
•Known bacteremia, severe sepsis or septic shock
•Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome)
•Hypersensitivity to tedizolid phosphate or any component in the formulation
•Hypersensitivity to all of the comparator drugs; hypersensitivity to a comparator drug does not preclude participation if an alternative comparator can be used
•For subjects with wound infections: history of hypersensitivity to ceftazidime, aztreonam, or any component of the aztreonam formulation, if aztreonam adjunctive therapy is required; history of hypersensitivity to metronidazole or any component of the formulation, if metronidazole adjunctive therapy is required
• Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors and serotonin 5- hydroxytryptamine receptor agonists (triptans) within 14 days prior to study drug administration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method