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

• Sponsor: MicuRx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03747497
• Collaborator: (none)
• Enrollment: 196
• Locations: 7
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site: 28
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases, Bacterial; Gram-Positive Bacterial Infections	Drug: contezolid acefosamil; Drug: linezolid 600 mg	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
• Actual Study Start Date: Nov 15, 2018
• Actual Primary Completion Date: Mar 26, 2019
• Actual Study Completion Date: Mar 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: contezolid acefosamil contezolid acefosamil 1500 mg IV x 1 dose, followed by 1000 mg IV q12h for at least 3 total IV doses, followed by 1300 mg PO q12h for 10 to 14 days	Drug: contezolid acefosamil; IV and oral contezolid acefosamil given twice a day for 10 to 14 days
Active Comparator: linezolid linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days	Drug: linezolid 600 mg; IV and oral linezolid given twice a day for 10 to 14 days; Other Names: Zyvox

Outcome Measures

Primary Outcome Measures

1. Early Clinical Response at the Early Assessment Visit (ITT Population) [48 to 72 hours after the start of study drug]

   Subjects in the ITT population who had clinical responses at Early Assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)

• Diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

• Uncomplicated skin infections

• Severe sepsis or septic shock

• ABSSSI solely due to Gram-negative pathogens

• Prior systemic antibiotics within 96 hours of randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MicuRx Site #106	Chula Vista	California	United States	91911
2	MicuRx Site #103	La Mesa	California	United States	91942
3	MicuRx Site #102	Long Beach	California	United States	90806
4	MicuRx Site #104	Stockton	California	United States	95204
5	MicuRx Site #107	Butte	Montana	United States	59701
6	MicuRx Site #105	Las Vegas	Nevada	United States	89106
7	MicuRx Site #108	Las Vegas	Nevada	United States	89109

Sponsors and Collaborators

• MicuRx

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 19, 2018
• Statistical Analysis Plan - May 28, 2019

More Information

Publications

None provided.

• Responsible Party: MicuRx
• ClinicalTrials.gov Identifier: NCT03747497
• Other Study ID Numbers: MRX4-201
• First Posted: Nov 20, 2018
• Last Update Posted: Apr 30, 2021
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MicuRx: ABSSSI; Acute bacterial skin and skin structure infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial; Gram-Positive Bacterial Infections; Skin Diseases; Linezolid

Study Results

Participant Flow

Recruitment Details	196 subjects were randomized

Arm/Group Title	Contezolid Acefosamil	Linezolid
Arm/Group Description	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 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
Period Title: Overall Study
STARTED	131	65
COMPLETED	106	55
NOT COMPLETED	25	10

Baseline Characteristics

Arm/Group Title	Contezolid Acefosamil	Linezolid	Total
Arm/Group Description	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 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h	Total of all reporting groups
Overall Participants	131	65	196
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.9 (11.87)	43.7 (10.94)	44.5 (11.57)
Sex: Female, Male (Count of Participants)
Female	52 39.7%	18 27.7%	70 35.7%
Male	79 60.3%	47 72.3%	126 64.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	51 38.9%	28 43.1%	79 40.3%
Not Hispanic or Latino	80 61.1%	37 56.9%	117 59.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	109 83.2%	58 89.2%	167 85.2%
Black or African American	8 6.1%	4 6.2%	12 6.1%
Asian	2 1.5%	1 1.5%	3 1.5%
American Indian or Alaska Native	5 3.8%	1 1.5%	6 3.1%
Native Hawaiian or Other Pacific Islander	2 1.5%	0 0%	2 1%
Other	5 3.8%	1 1.5%	6 3.1%

Outcome Measures

1. Primary Outcome

Title	Early Clinical Response at the Early Assessment Visit (ITT Population)
Description	Subjects in the ITT population who had clinical responses at Early Assessment
Time Frame	48 to 72 hours after the start of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contezolid Acefosamil	Linezolid
Arm/Group Description	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 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
Measure Participants	131	65
Responder	102 77.9%	51 78.5%
Non-Responder	3 2.3%	6 9.2%
Indeterminate	26 19.8%	8 12.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Contezolid Acefosamil, Linezolid
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -14.0 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	28 Days
Arm/Group Title	Contezolid Acefosamil		Linezolid
Arm/Group Description	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 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
All Cause Mortality
	Contezolid Acefosamil		Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/123 (0.8%)		1/64 (1.6%)
Serious Adverse Events
	Contezolid Acefosamil		Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/123 (2.4%)		1/64 (1.6%)
Infections and infestations
Wound Infection	1/123 (0.8%)		0/64 (0%)
Bacteremia	1/123 (0.8%)		0/64 (0%)
Injury, poisoning and procedural complications
Road traffic accident	0/123 (0%)		1/64 (1.6%)
Overdose	1/123 (0.8%)		0/64 (0%)
Other (Not Including Serious) Adverse Events
	Contezolid Acefosamil		Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/123 (44.7%)		27/64 (42.2%)
Gastrointestinal disorders
Nausea	18/123 (14.6%)		5/64 (7.8%)
Vomiting	9/123 (7.3%)		5/64 (7.8%)
Diarrhoea	4/123 (3.3%)		0/64 (0%)
Flatulence	1/123 (0.8%)		2/64 (3.1%)
Constipation	0/123 (0%)		2/64 (3.1%)
General disorders
Injection site extravasation	3/123 (2.4%)		2/64 (3.1%)
Oedema peripheral	1/123 (0.8%)		2/64 (3.1%)
Infections and infestations
Cellulitis	9/123 (7.3%)		7/64 (10.9%)
Abscess	6/123 (4.9%)		2/64 (3.1%)
Wound infection	6/123 (4.9%)		3/64 (4.7%)
Upper respiratory tract infection	5/123 (4.1%)		0/64 (0%)
Nervous system disorders
Headache	5/123 (4.1%)		2/64 (3.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.