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The purpose of this study is to determine whether MRX-I 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 |
|---|---|---|---|
| MRX-I | Experimental | MRX-I tablets 800 mg given twice a day for 10 days |
|
| Linezolid | Active Comparator | Linezolid 600 mg given twice a day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRX-I | Drug | Oral MRX-I 800mg given twice a day for 10 days |
| |
| Linezolid |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline |
| 48-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline | Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | MRX-I | MRX-I tablets 800 mg given twice a day for 10 days MRX-I: Oral MRX-I 800mg given twice a day for 10 days |
| FG001 | Linezolid | Linezolid 600 mg given twice a day for 10 days Linezolid: Oral linezolid 600mg given twice a day for 10 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MRX-I | MRX-I tablets 800 mg given twice a day for 10 days MRX-I: Oral MRX-I 800mg given twice a day for 10 days |
| BG001 | Linezolid | Linezolid 600 mg given twice a day for 10 days Linezolid: Oral linezolid 600mg given twice a day for 10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline |
| Intent-to-Treat (ITT) | Posted | Count of Participants | Participants | 48-72 hours |
|
39 days
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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 | MRX-I | MRX-I tablets 800 mg given twice a day for 10 days MRX-I: Oral MRX-I 800mg given twice a day for 10 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | Moderate SAE unrelated to study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
Proof of concept study was limited in size and scope. Given the number of male to female subjects, the interpretation of the results were limited. Since the duration of therapy was up to 10 days, assessment of long-term safety risks was limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John M. Sall, Global Head of Regulatory | MicuRx Pharmaceuticals Inc. | 919-670-7803 | jsall@micurx.com |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Drug |
Oral linezolid 600mg given twice a day for 10 days |
|
|
| Instructions not followed |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline | Intent-to-Treat (ITT) | Posted | Count of Participants | Participants | Day 10 |
|
|
|
| 0 |
| 80 |
| 1 |
| 80 |
| 47 |
| 80 |
| EG001 | Linezolid | Linezolid 600 mg given twice a day for 10 days Linezolid: Oral linezolid 600mg given twice a day for 10 days | 0 | 40 | 0 | 40 | 12 | 40 |
|
| Abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |