Acute Bacterial Skin and Skin Structure Infections
Conditions
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.
Interventions
Tedizolid phosphate IV solution or oral suspension
DRUGComparator
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
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single blinded
Eligibility
Sex/Gender
ALL
Age
1 Days to 11 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil, Bulgaria, Georgia, Germany, Guatemala, Latvia, Lithuania, Mexico, Poland, Russia, South Africa, Turkey (Türkiye), Ukraine, United States
Participant flow
Pre-assignment details
A total of100 participants were randomized and received treatment and were evaluable for all safety and efficacy analyses. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \<28 Days Neonates) and Cohort 4: Comparator (Birth to \<28 Days Term & preterm neonates) arms.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Tedizolid Phosphate 6 to <12 Years Participants received 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. | 44 |
| Cohort 1: Comparator 6 to <12 Years Participants received comparator IV and/or oral per local standard of care for 10 to 14 days. | 15 |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years Participants received 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. | 16 |
| Cohort 2: Comparator 2 to <6 Years Participants received comparator IV and/or oral per local standard of care for 10 to 14 days. | 5 |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years Participants received 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. | 15 |
| Cohort 3: Comparator 28 Days to <2 Years Participants received comparator IV and/or oral per local standard of care for 10 to 14 days. | 5 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Parent/Guardian | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Tedizolid Phosphate 6 to <12 Years | Cohort 1: Comparator 6 to <12 Years | Cohort 2: Tedizolid Phosphate 2 to <6 Years | Cohort 2: Comparator 2 to <6 Years | Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Cohort 3: Comparator 28 Days to <2 Years | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 8.5 years STANDARD_DEVIATION 1.7 | 9.2 years STANDARD_DEVIATION 1.4 | 3.1 years STANDARD_DEVIATION 1.1 | 3.4 years STANDARD_DEVIATION 1.1 | 0.9 years STANDARD_DEVIATION 0.2 | 1.0 years STANDARD_DEVIATION 0.1 | 6.0 years STANDARD_DEVIATION 3.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 13 Participants | 11 Participants | 4 Participants | 13 Participants | 4 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 9 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 15 Participants | 13 Participants | 4 Participants | 4 Participants | 3 Participants | 80 Participants |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 8 Participants | 2 Participants | 11 Participants | 2 Participants | 47 Participants |
| Sex: Female, Male Male | 28 Participants | 7 Participants | 8 Participants | 3 Participants | 4 Participants | 3 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 15 | 0 / 16 | 0 / 5 | 0 / 15 | 0 / 5 |
| other Total, other adverse events | 4 / 44 | 2 / 15 | 7 / 16 | 2 / 5 | 7 / 15 | 2 / 5 |
| serious Total, serious adverse events | 0 / 44 | 0 / 15 | 0 / 16 | 0 / 5 | 0 / 15 | 0 / 5 |
Outcome results
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE
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.
Time frame: Up to approximately day 15
Population: All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \<28 Days Neonates) and Cohort 4: Comparator (Birth to \<28 Days Term \& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Tedizolid Phosphate 6 to <12 Years | Number of Participants Who Discontinued Study Treatment Due to an AE | 0 Participants |
| Cohort 1: Comparator 6 to <12 Years | Number of Participants Who Discontinued Study Treatment Due to an AE | 0 Participants |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years | Number of Participants Who Discontinued Study Treatment Due to an AE | 0 Participants |
| Cohort 2: Comparator 2 to <6 Years | Number of Participants Who Discontinued Study Treatment Due to an AE | 0 Participants |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Number of Participants Who Discontinued Study Treatment Due to an AE | 0 Participants |
| Cohort 3: Comparator 28 Days to <2 Years | Number of Participants Who Discontinued Study Treatment Due to an AE | 0 Participants |
Primary
Number of Participants Who Experienced an Adverse Event (AE)
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.
Time frame: Up to approximately 35 days
Population: All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \<28 Days Neonates) and Cohort 4: Comparator (Birth to \<28 Days Term \& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Tedizolid Phosphate 6 to <12 Years | Number of Participants Who Experienced an Adverse Event (AE) | 7 Participants |
| Cohort 1: Comparator 6 to <12 Years | Number of Participants Who Experienced an Adverse Event (AE) | 2 Participants |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years | Number of Participants Who Experienced an Adverse Event (AE) | 7 Participants |
| Cohort 2: Comparator 2 to <6 Years | Number of Participants Who Experienced an Adverse Event (AE) | 2 Participants |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Number of Participants Who Experienced an Adverse Event (AE) | 7 Participants |
| Cohort 3: Comparator 28 Days to <2 Years | Number of Participants Who Experienced an Adverse Event (AE) | 2 Participants |
Primary
Number of Participants With Hematopoietic Cytopenias
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.
Time frame: Up to approximately 35 days
Population: All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \<28 Days Neonates) and Cohort 4: Comparator (Birth to \<28 Days Term \& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Tedizolid Phosphate 6 to <12 Years | Number of Participants With Hematopoietic Cytopenias | 0 Participants |
| Cohort 1: Comparator 6 to <12 Years | Number of Participants With Hematopoietic Cytopenias | 0 Participants |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years | Number of Participants With Hematopoietic Cytopenias | 1 Participants |
| Cohort 2: Comparator 2 to <6 Years | Number of Participants With Hematopoietic Cytopenias | 0 Participants |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Number of Participants With Hematopoietic Cytopenias | 1 Participants |
| Cohort 3: Comparator 28 Days to <2 Years | Number of Participants With Hematopoietic Cytopenias | 0 Participants |
Secondary
Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment
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.
Time frame: Up to approximately 25 days
Population: CE participants included all randomized participants who received at least one dose of study intervention, had a confirmed ABSSSI, had a suspected or documented gram+ infection from BL, received a sufficient course of therapy. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \<28 Days Neonates) and Cohort 4: Comparator (Birth to \<28 Days Term \& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Tedizolid Phosphate 6 to <12 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.00 Percentage of Participants |
| Cohort 1: Tedizolid Phosphate 6 to <12 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| Cohort 1: Comparator 6 to <12 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.0 Percentage of Participants |
| Cohort 1: Comparator 6 to <12 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.0 Percentage of Participants |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| Cohort 2: Comparator 2 to <6 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.00 Percentage of Participants |
| Cohort 2: Comparator 2 to <6 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.0 Percentage of Participants |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| Cohort 3: Comparator 28 Days to <2 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.0 Percentage of Participants |
| Cohort 3: Comparator 28 Days to <2 Years | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| All Cohorts: Tedizolid Phosphate | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| All Cohorts: Tedizolid Phosphate | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.00 Percentage of Participants |
| All Cohorts: Comparator | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Success | 100.0 Percentage of Participants |
| All Cohorts: Comparator | Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
95% CI: [0, 0]
95% CI: [0, 0]
95% CI: [0, 0]
95% CI: [0, 0]
Secondary
Percentage of Participants With Clinical Response (CR) Per Investigator Assessment
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.
Time frame: Up to approximately 25 days
Population: All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \<28 Days Neonates) and Cohort 4: Comparator (Birth to \<28 Days Term \& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Tedizolid Phosphate 6 to <12 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 93.2 Percentage of Participants |
| Cohort 1: Tedizolid Phosphate 6 to <12 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 6.8 Percentage of Participants |
| Cohort 1: Comparator 6 to <12 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 86.7 Percentage of Participants |
| Cohort 1: Comparator 6 to <12 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 13.3 Percentage of Participants |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 87.5 Percentage of Participants |
| Cohort 2: Tedizolid Phosphate 2 to <6 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 12.5 Percentage of Participants |
| Cohort 2: Comparator 2 to <6 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 100.00 Percentage of Participants |
| Cohort 2: Comparator 2 to <6 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 100.0 Percentage of Participants |
| Cohort 3: Tedizolid Phosphate 28 Days to <2 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| Cohort 3: Comparator 28 Days to <2 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 100.0 Percentage of Participants |
| Cohort 3: Comparator 28 Days to <2 Years | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 0.0 Percentage of Participants |
| All Cohorts: Tedizolid Phosphate | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 6.7 Percentage of Participants |
| All Cohorts: Tedizolid Phosphate | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 93.3 Percentage of Participants |
| All Cohorts: Comparator | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Success | 92.0 Percentage of Participants |
| All Cohorts: Comparator | Percentage of Participants With Clinical Response (CR) Per Investigator Assessment | Clinical Failure or Indeterminate | 8.0 Percentage of Participants |
95% CI: [-12.2, 25.3]
95% CI: [-28.7, 3.7]
95% CI: [0, 0]
95% CI: [-10.7, 13.4]