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)
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| ClinicalTrials.gov Identifier: NCT03176134 |
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Recruitment Status :
Recruiting
First Posted : June 5, 2017
Last Update Posted : February 28, 2023
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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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 less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Bacterial Skin and Skin Structure Infections | Drug: Tedizolid phosphate Drug: Comparator | Phase 3 |
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 (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| 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 Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) |
| Actual Study Start Date : | January 20, 2019 |
| Estimated Primary Completion Date : | June 28, 2024 |
| Estimated Study Completion Date : | June 28, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1: 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 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
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Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
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Active Comparator: Cohort 1 Comparator: 6 to <12 Years
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
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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 |
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Experimental: Cohort 2: 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 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
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Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
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Active Comparator: Cohort 2 Comparator: 2 to <6 Years
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
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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 |
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Experimental: Cohort 3: Tedizolid phosphate 28 Days to <2 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 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
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Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
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Active Comparator: Cohort 3: Comparator: 28 Days to <2 Years
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
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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 |
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Experimental: Cohort 4: 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.
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Drug: Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
Other Names:
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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 :
- Percentage of participants with ≥1 adverse events (AEs) [ 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 with one or more AEs will be reported.
- Percentage of participants discontinuing from study therapy due to AEs [ 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 AE. The percentage of participants discontinued from the study due to an AE will be reported.
- Percentage of participants with 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 :
- Percentage of participants with 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:
- Has a parent/legally acceptable representative who is able to give documented informed consent
- Has ABSSSI, defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection
- Local symptoms of ABSSSI that started within 14 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 1) <48 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
- 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 (ECG) 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)
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
Contacts
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
Locations
Show 57 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme LLC |
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT03176134 |
| Other Study ID Numbers: |
1986-018 MK-1986-018 ( Other Identifier: Merck Protocol Number ) 2016-003884-20 ( EudraCT Number ) |
| First Posted: | June 5, 2017 Key Record Dates |
| Last Update Posted: | February 28, 2023 |
| Last Verified: | February 2023 |
| 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 |
| 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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Infections Communicable Diseases Skin Diseases, Bacterial Disease Attributes Pathologic Processes Bacterial Infections Bacterial Infections and Mycoses |
Skin Diseases, Infectious Skin Diseases Tedizolid Tedizolid phosphate Anti-Bacterial Agents Anti-Infective Agents |