A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)

Conditions:Skin and Soft Tissue Infections, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Age Range:Any - 11
Start Date:January 20, 2019
End Date:September 18, 2021
Contact:Toll Free Number

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A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate
(MK-1986) compared with comparator antibacterial agent in participants from birth to <12
years of age with acute bacterial skin and skin structure infections.

Participants will be randomized (3:1) to receive MK-1986 at a weight-based dose ≤200 mg/day,
intravenous (IV) and/or oral suspension for 6 or 10 days, or comparator IV and/or oral per
local standard of care for 10 or 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 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.

Inclusion Criteria:

- ABSSSI, defined as one of the following: 1) cellulitis/erysipelas, 2) major cutaneous
abscess, 3) wound infection

- Local symptoms of ABSSSI that started within 7 days before study start

- Suspected or documented Gram-positive bacterial infection

- Body weight >5th percentile and <95th percentile based on age.

Exclusion Criteria:

- Uncomplicated skin and skin structure infection

- ABSSSI due to or associated with disallowed etiology per protocol

- Received antibacterial therapy for treatment of the current episode of ABSSSI except
1) <24 hours of antibacterial therapy with a short-acting antibacterial drug, or 2)
response is considered to be failure (no improvement in signs and symptoms) after at
least 48 hours of therapy

- Topical antibacterial applied and remaining on the primary lesion >24 hours before

- Known bacteremia, severe sepsis, or septic shock

- Significant or life-threatening condition, disease, or organ system condition

- Recent history of opportunistic infections where the underlying cause of the infection
is still active, or is suspected to be at risk of opportunistic infection with unusual

- Received or is receiving treatment for active tuberculosis within 1 month of study

- Known or suspected severe neutropenia

- Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4
cell count <15% (HIV testing is not required for eligibility)

- Renal impairment that requires renal filtration

- Severe hepatic impairment

- Cardiac or electrocardiogram finding that would limit participation in the study

- Received an investigational medicinal product (not approved) within 30 days before
study start

- Investigational device present or removed within 30 days before study start

- Previously treated with tedizolid phosphate

- Contraindication, including hypersensitivity to tedizolid phosphate, other
oxazolidinones, or any component in the formulation

- Contraindication, including hypersensitivity to all available comparator drugs

- Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or
metronidazole adjunctive therapy, if adjunctive therapy is required

- Currently receiving topotecan, irinotecan, methotrexate, or rosuvastatin

- Female who is pregnant or nursing or is of childbearing potential and not abstinent;
or male who is not abstinent

- Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective
serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists

- Identified as having used illicit drugs (urine drug screening not required for entry).
We found this trial at
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(312) 227-4000
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