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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    120
  • sponsor
    Merck Sharp & Dohme Corp.
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Updated on 18 April 2021
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Summary

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.

Description

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.

Details
Condition Acute Bacterial Skin and Skin Structure Infections
Treatment Comparator, MK-1986, Tedizolid phosphate
Clinical Study IdentifierNCT03176134
SponsorMerck Sharp & Dohme Corp.
Last Modified on18 April 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Is your age less than or equal to 11 yrs?
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have any of these conditions: Do you have Acute Bacterial Skin and Skin Structure Infections??
Do you have Acute Bacterial Skin and Skin Structure Infections?
Gender: Male or Female
Has a parent/legally acceptable representative who is able to give documented informed consent
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 3.2 kg

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
<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 randomization
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 pathogens
Received or is receiving treatment for active tuberculosis within 1 month of study start
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
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 drug)
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 (triptans)
Identified as having used illicit drugs (urine drug screening not required for entry)
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