This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).
Participants will be randomized (3:1) to receive tedizolid phosphate at a weight-based dose ≤200 mg/day, intravenous (IV) and/or oral suspension for 6 to 10 days, or comparator IV and/or oral per local standard of care for 10 to 14 days. The switch from IV to oral administration can be made at any time based on 1) no worsening of the primary skin lesion, 2) last temperature \<37.7 °C, and 3) primary acute bacterial skin and skin structure infection (ABSSSI) site has not worsened and at least 1 site has improved from Baseline. The potential 4-day treatment extension will be based on clinical need as judged by the investigator, considering the following criteria: 1) ≥40% reduction in primary lesion size, 2) reduction in pain, and 3) no new signs and symptoms and no complications attributable to ABSSSI compared with Baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Tedizolid phosphate IV solution or oral suspension
Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care
Number of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.
Time frame: Up to approximately 35 days
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. The number of participants who discontinued study treatment due to an AE were reported.
Time frame: Up to approximately day 15
Number of Participants With Hematopoietic Cytopenias
Hematopoietic cytopenia is a condition where there is a lower-than-normal amount of one or multiple kinds of blood cells. A standardized Medical Dictionary for Regulatory Activities (MedDRA) query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported.
Time frame: Up to approximately 35 days
Percentage of Participants With Clinical Response (CR) Per Investigator Assessment
CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \& symptoms, absence/near resolution of regional/systemic signs of infection if present at baseline (BL) \& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event (TEAE) leading to study drug discontinuation \& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \& 3 \& all cohorts together were reported, \& failure \& indeterminate responses were pooled.
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Rady Children's Hospital-San Diego ( Site 0118)
San Diego, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129)
Chicago, Illinois, United States
Children's Hospital of Michigan ( Site 0100)
Detroit, Michigan, United States
William Beaumont Hospital ( Site 0108)
Royal Oak, Michigan, United States
St. Louis Children's Hospital ( Site 0127)
St Louis, Missouri, United States
Cook Children's Medical Center ( Site 0124)
Fort Worth, Texas, United States
Baylor College of Medicine - Texas Children's Hospital ( Site 0107)
Houston, Texas, United States
Children's Hospital of Richmond at VCU ( Site 0123)
Richmond, Virginia, United States
Hospital Pequeno Principe ( Site 0276)
Curitiba, Paraná, Brazil
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277)
Recife, Pernambuco, Brazil
...and 48 more locations
Time frame: Up to approximately 25 days
Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment
CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \& symptoms, absence/near resolution of regional/systemic signs of infection if present at BL \& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event leading to study drug discontinuation \& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \& 3 and all cohorts together were reported, \& failure \& indeterminate responses were pooled.
Time frame: Up to approximately 25 days