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)

Phase 3

Completed

• Conditions: Acute Bacterial Skin and Skin Structure Infections
• Interventions: Drug: Tedizolid phosphate; Drug: Comparator

• Registration Number: NCT03176134
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

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 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 Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2019-01-20
• Primary Completion: 2023-07-06
• Study Completion: 2023-07-06
• Results First Submitted: 2024-06-10
• Results First Submitted QC: 2024-06-10
• Results First Posted: 2024-07-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Has a parent/legally acceptable representative who is able to give documented informed consent
• Has acute bacterial skin and skin structure infections (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

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 end of treatment (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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Tedizolid phosphate 6 to <12 Years	Tedizolid phosphate	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.
Cohort 2: Tedizolid phosphate 2 to <6 Years	Tedizolid phosphate	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.
Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates	Comparator	Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days.
Cohort 1: Comparator 6 to <12 Years	Comparator	Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.
Cohort 3: Tedizolid phosphate 28 Days to <2 Years	Tedizolid phosphate	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.
Cohort 2: Comparator 2 to <6 Years	Comparator	Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.
Cohort 3: Comparator 28 Days to <2 Years	Comparator	Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.
Cohort 4: Tedizolid phosphate Birth to <28 Days Term and Preterm Neonates	Tedizolid phosphate	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 (NCT03217565) covering the age range.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hematopoietic Cytopenias	Up to approximately 35 days	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.
Number of Participants Who Experienced an Adverse Event (AE)	Up to approximately 35 days	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.
Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately day 15	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Response (CR) Per Investigator Assessment	Up to approximately 25 days	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.
Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment	Up to approximately 25 days	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.

Trial Locations

Locations (58)

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); 🇺🇸 Saint 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, Parana, Brazil

Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277); 🇧🇷 Recife, Pernambuco, Brazil

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