Trial Outcomes & Findings for 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) (NCT NCT03176134)

Last Updated: 2025-07-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Up to approximately 35 days

Results posted on

2025-07-31

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	Cohort 1: Comparator 6 to <12 Years Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	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.	Cohort 2: Comparator 2 to <6 Years Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	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.	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.
Overall Study STARTED	44	15	16	5	15	5
Overall Study COMPLETED	42	13	14	5	15	5
Overall Study NOT COMPLETED	2	2	2	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Cohort 1: Comparator 6 to <12 Years Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	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.	Cohort 2: Comparator 2 to <6 Years Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	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.	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.	Cohort 4: Tedizolid Phosphate Birth to <28 Days Term and Preterm Neonates Participants were to receive Tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose was to be determined based on results of another study (NCT03217565) covering the age range. No participants were enrolled in this arm.	Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates Participants were to receive comparator IV and/or oral as per local standard of care for 10-14 days. No participants were enrolled in this arm.
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

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Tedizolid Phosphate 6 to <12 Years n=44 Participants 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.	Cohort 1: Comparator 6 to <12 Years n=15 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 2: Tedizolid Phosphate 2 to <6 Years n=16 Participants 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.	Cohort 2: Comparator 2 to <6 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years n=15 Participants 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.	Cohort 3: Comparator 28 Days to <2 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Total n=100 Participants Total of all reporting groups
Age, Continuous	8.5 years STANDARD_DEVIATION 1.7 • n=5 Participants	9.2 years STANDARD_DEVIATION 1.4 • n=7 Participants	3.1 years STANDARD_DEVIATION 1.1 • n=5 Participants	3.4 years STANDARD_DEVIATION 1.1 • n=4 Participants	0.9 years STANDARD_DEVIATION 0.2 • n=21 Participants	1.0 years STANDARD_DEVIATION 0.1 • n=10 Participants	6.0 years STANDARD_DEVIATION 3.6 • n=115 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants	2 Participants n=10 Participants	47 Participants n=115 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	53 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	17 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants	4 Participants n=10 Participants	83 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants	1 Participants n=10 Participants	11 Participants n=115 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	80 Participants n=115 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	8 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Tedizolid Phosphate 6 to <12 Years n=44 Participants 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.	Cohort 1: Comparator 6 to <12 Years n=15 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 2: Tedizolid Phosphate 2 to <6 Years n=16 Participants 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.	Cohort 2: Comparator 2 to <6 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years n=15 Participants 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.	Cohort 3: Comparator 28 Days to <2 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	All Cohorts: Tedizolid Phosphate Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) 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.	All Cohorts: Comparator Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) received comparator IV and/or oral per local standard of care for 10 to 14 days.
Number of Participants Who Experienced an Adverse Event (AE)	7 Participants	2 Participants	7 Participants	2 Participants	7 Participants	2 Participants	—	—

PRIMARY outcome

Timeframe: Up to approximately day 15

Outcome measures

Outcome measures
Measure	Cohort 1: Tedizolid Phosphate 6 to <12 Years n=44 Participants 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.	Cohort 1: Comparator 6 to <12 Years n=15 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 2: Tedizolid Phosphate 2 to <6 Years n=16 Participants 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.	Cohort 2: Comparator 2 to <6 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years n=15 Participants 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.	Cohort 3: Comparator 28 Days to <2 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	All Cohorts: Tedizolid Phosphate Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) 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.	All Cohorts: Comparator Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) received comparator IV and/or oral per local standard of care for 10 to 14 days.
Number of Participants Who Discontinued Study Treatment Due to an AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Tedizolid Phosphate 6 to <12 Years n=44 Participants 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.	Cohort 1: Comparator 6 to <12 Years n=15 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 2: Tedizolid Phosphate 2 to <6 Years n=16 Participants 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.	Cohort 2: Comparator 2 to <6 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years n=15 Participants 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.	Cohort 3: Comparator 28 Days to <2 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	All Cohorts: Tedizolid Phosphate Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) 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.	All Cohorts: Comparator Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) received comparator IV and/or oral per local standard of care for 10 to 14 days.
Number of Participants With Hematopoietic Cytopenias	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Tedizolid Phosphate 6 to <12 Years n=44 Participants 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.	Cohort 1: Comparator 6 to <12 Years n=15 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 2: Tedizolid Phosphate 2 to <6 Years n=16 Participants 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.	Cohort 2: Comparator 2 to <6 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years n=15 Participants 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.	Cohort 3: Comparator 28 Days to <2 Years n=5 Participants Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	All Cohorts: Tedizolid Phosphate n=75 Participants Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) 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.	All Cohorts: Comparator n=25 Participants Participants in Cohort 1 (age: 6 to \<12 years), Cohort 2 (age: 2 to \<6 years), and Cohort 3 (age: 28 days to \<2 years) received comparator IV and/or oral per local standard of care for 10 to 14 days.
Percentage of Participants With Clinical Response (CR) Per Investigator Assessment Clinical Success	93.2 Percentage of Participants Interval 81.3 to 98.6	86.7 Percentage of Participants Interval 59.5 to 98.3	87.5 Percentage of Participants Interval 61.7 to 98.4	100.00 Percentage of Participants Interval 47.8 to 100.0	100.0 Percentage of Participants Interval 78.2 to 100.0	100.0 Percentage of Participants Interval 47.8 to 100.0	93.3 Percentage of Participants Interval 85.1 to 97.8	92.0 Percentage of Participants Interval 74.0 to 99.0
Percentage of Participants With Clinical Response (CR) Per Investigator Assessment Clinical Failure or Indeterminate	6.8 Percentage of Participants Interval 1.4 to 18.7	13.3 Percentage of Participants Interval 1.7 to 40.5	12.5 Percentage of Participants Interval 1.6 to 38.3	0.0 Percentage of Participants NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.	0.0 Percentage of Participants NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.	0.0 Percentage of Participants NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.	6.7 Percentage of Participants Interval 2.2 to 14.9	8.0 Percentage of Participants Interval 1.0 to 26.0

SECONDARY outcome

Timeframe: 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.

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.