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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03176134
Recruitment Status : Suspended (COVID-19)
First Posted : June 5, 2017
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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 <12 years of age with acute bacterial skin and skin structure infections.

Condition or disease Intervention/treatment Phase
Acute Bacterial Skin and Skin Structure Infections Drug: Tedizolid phosphate Drug: Comparator Phase 3

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : September 18, 2021
Estimated Study Completion Date : September 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tedizolid phosphate: 6 to <12 Years
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 10 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
  • MK-1986
  • TR-701 FA

Active Comparator: Comparator: 6 to <12 Years
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Drug: Comparator
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

Experimental: Tedizolid phosphate: 2 to <6 Years
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 10 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
  • MK-1986
  • TR-701 FA

Active Comparator: Comparator: 2 to <6 Years
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Drug: Comparator
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

Experimental: Tedizolid phosphate: 28 Days to <2 Years
Participants will receive tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose is to be determined based on results of another study covering the age range.
Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
  • MK-1986
  • TR-701 FA

Active Comparator: Comparator: 28 Days to <2 Years
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Drug: Comparator
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

Experimental: Tedizolid phosphate: Birth to <28 Days Neonates
Participants will receive tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose is to be determined based on results of another study covering the age range.
Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
  • MK-1986
  • TR-701 FA

Active Comparator: Comparator: Birth to <28 Days (Term and preterm neonates)
Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days
Drug: Comparator
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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to Day 35 ]
    An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants with one or more AEs will be reported.

  2. Study Discontinuations due to an Adverse Event [ Time Frame: Up to Day 35 ]
    An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants discontinued from the study due to an AE will be reported.

  3. Hematopoietic Cytopenias [ Time Frame: Up to Day 35 ]
    A standardized MedDRA query for hematopoietic cytopenia will be conducted. The percentage of participants with a hematopoietic cytopenia will be reported.


Secondary Outcome Measures :
  1. Clinical Success [ Time Frame: Day 25 ]
    The investigator's assessment of clinical response will be conducted at the Test of Cure (TOC) visit, approximately 25 days after the first infusion. Clinical success is defined as 1) resolution or near-resolution of most signs and symptoms, 2) absence or near-resolution of signs of infection, and 3) no new signs, symptoms, or complications attributable to the infections (no further antibiotic therapy required for the primary lesion). The percentage of participants with clinical success will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  • 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 (triptans)
  • Identified as having used illicit drugs (urine drug screening not required for entry).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176134


Locations
Show Show 34 study locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03176134    
Other Study ID Numbers: 1986-018
2016-003884-20 ( EudraCT Number )
MK-1986-018 ( Other Identifier: Merck Protocol Number )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Skin Diseases
Tedizolid
Tedizolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents