Trial Outcomes & Findings for Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection (NCT NCT03747497)

Last Updated: 2022-11-08

Results Overview

Early clinical response assessment based on the electronic case report form (eCRF) data at Early Assessment (48-72 hours after start of study drug) where a successful response (i.e., "responder") was defined as a reduction in primary ABSSSI lesion size ≥20% compared to baseline, and the subject did not receive a non-protocol specified systemic antibacterial agent with activity against Gram-positive organisms for the treatment of ABSSSI and did not die of any cause up to Early Assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

196 participants

Primary outcome timeframe

48 to 72 hours after the start of study drug

Results posted on

2022-11-08

Participant Flow

196 subjects were randomized

Participant milestones

Participant milestones
Measure	Contezolid Acefosamil Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h	Linezolid Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
Overall Study STARTED	131	65
Overall Study COMPLETED	106	55
Overall Study NOT COMPLETED	25	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contezolid Acefosamil n=131 Participants Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h	Linezolid n=65 Participants Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h	Total n=196 Participants Total of all reporting groups
Age, Continuous	44.9 years STANDARD_DEVIATION 11.87 • n=5 Participants	43.7 years STANDARD_DEVIATION 10.94 • n=7 Participants	44.5 years STANDARD_DEVIATION 11.57 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	18 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	47 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	51 Participants n=5 Participants	28 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	37 Participants n=7 Participants	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	109 Participants n=5 Participants	58 Participants n=7 Participants	167 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 to 72 hours after the start of study drug

Outcome measures

Outcome measures
Measure	Contezolid Acefosamil n=131 Participants Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h	Linezolid n=65 Participants Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
Early Clinical Response at the Early Assessment Visit (ITT Population) Responder	102 Participants	51 Participants
Early Clinical Response at the Early Assessment Visit (ITT Population) Non-Responder	3 Participants	6 Participants
Early Clinical Response at the Early Assessment Visit (ITT Population) Indeterminate	26 Participants	8 Participants

Adverse Events

Contezolid Acefosamil

Serious events: 3 serious events

Other events: 55 other events

Deaths: 1 deaths

Linezolid

Serious events: 1 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Contezolid Acefosamil n=123 participants at risk Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h	Linezolid n=64 participants at risk Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	1.6% 1/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Injury, poisoning and procedural complications Overdose	0.81% 1/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	0.00% 0/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Infections and infestations Wound Infection	0.81% 1/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	0.00% 0/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Infections and infestations Bacteremia	0.81% 1/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	0.00% 0/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.

Other adverse events

Other adverse events
Measure	Contezolid Acefosamil n=123 participants at risk Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h	Linezolid n=64 participants at risk Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
Gastrointestinal disorders Nausea	14.6% 18/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	7.8% 5/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Gastrointestinal disorders Vomiting	7.3% 9/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	7.8% 5/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Gastrointestinal disorders Diarrhoea	3.3% 4/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	0.00% 0/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Gastrointestinal disorders Flatulence	0.81% 1/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	3.1% 2/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Gastrointestinal disorders Constipation	0.00% 0/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	3.1% 2/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Infections and infestations Cellulitis	7.3% 9/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	10.9% 7/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Infections and infestations Abscess	4.9% 6/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	3.1% 2/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Infections and infestations Wound infection	4.9% 6/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	4.7% 3/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Infections and infestations Upper respiratory tract infection	4.1% 5/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	0.00% 0/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
General disorders Injection site extravasation	2.4% 3/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	3.1% 2/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
General disorders Oedema peripheral	0.81% 1/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	3.1% 2/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.
Nervous system disorders Headache	4.1% 5/123 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.	3.1% 2/64 • 28 Days The ITT Population (N=131) consists of all randomized subjects regardless of whether or not the subject received study drug. The Safety Population consists of all randomized subjects who received any amount of study drug, and included 123 subjects in the contezolid acefosamil group and 64 subjects (98.5%) in the linezolid group. All safety analyses were conducted in this population and were analyzed by the treatment the subject actually received.

Additional Information

Study Director

MicuRx Pharmaceuticals, Inc.

Phone: 510-782-2022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place