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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| contezolid acefosamil | Experimental | 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 |
|
| linezolid | Active Comparator | linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contezolid acefosamil | Drug | IV and oral contezolid acefosamil given twice a day for 10 to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Clinical Response at the Early Assessment Visit (ITT Population) | 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. | 48 to 72 hours after the start of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MicuRx Site #106 | Chula Vista | California | 91911 | United States | ||
| MicuRx Site #103 |
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196 subjects were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Linezolid | Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2018 | Apr 1, 2021 |
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| linezolid 600 mg | Drug | IV and oral linezolid given twice a day for 10 to 14 days |
|
|
| La Mesa |
| California |
| 91942 |
| United States |
| MicuRx Site #102 | Long Beach | California | 90806 | United States |
| MicuRx Site #104 | Stockton | California | 95204 | United States |
| MicuRx Site #107 | Butte | Montana | 59701 | United States |
| MicuRx Site #105 | Las Vegas | Nevada | 89106 | United States |
| MicuRx Site #108 | Las Vegas | Nevada | 89109 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Linezolid | Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early Clinical Response at the Early Assessment Visit (ITT Population) | 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. | Posted | Count of Participants | Participants | 48 to 72 hours after the start of study drug |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 123 | 3 | 123 | 55 | 123 |
| EG001 | Linezolid | Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h | 1 | 64 | 1 | 64 | 27 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Abscess | Infections and infestations | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Injection site extravasation | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | MicuRx Pharmaceuticals, Inc. | 510-782-2022 | info@micrux.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2019 | Apr 1, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D016908 | Gram-Positive Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Indeterminate |
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