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This is a Phase II, multi-center, randomized, double-blind study comparing the safety and efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and skin structure infection.
The purpose of the study is to determine the efficacy of 2 dose regimens of BC-3781 versus the licensed medicinal product vancomycin over 5 to 14 days. The population in this study will be patients with an acute bacterial skin and skin structure infection (ABSSSI) and they will receive treatment with one of two doses of BC-3781 or vancomycin, a standard treatment for this condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BC-3781 dose 100mg | Experimental |
| |
| BC-3781 dose 150mg | Experimental |
| |
| Vancomycin | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BC-3781 | Drug | BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required. | Test of Cure (TOC), 7 - 14 days post final treatment |
| Clinical Response | Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required | Test of Cure (TOC), 7 - 14 days post final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William T. Prince, Dr. | Nabriva Therapeutics AG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC-3781 Study Center 002 | Chula Vista | California | 91911 | United States | ||
| BC-3781 Study Center 001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25348519 | Derived | Rubino CM, Xue B, Bhavnani SM, Prince WT, Ivezic-Schoenfeld Z, Wicha WW, Ambrose PG. Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Jan;59(1):282-8. doi: 10.1128/AAC.02033-13. Epub 2014 Oct 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BC-3781 Dose 100mg | BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| FG001 | BC-3781 Dose 150mg | BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BC-3781 | Drug | BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
|
| Vancomycin | Drug | Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
|
| La Mesa |
| California |
| 91942 |
| United States |
| BC-3781 Study Center 003 | Oceanside | California | 92056 | United States |
| BC-3781 Study Center 012 | Columbus | Georgia | 31904 | United States |
| BC-3781 Study Center 018 | Savannah | Georgia | 31406 | United States |
| BC-3781 Study Center 021 | Baton Rouge | Louisiana | 70808 | United States |
| BC-3781 Study Center 023 | Lafayette | Louisiana | 70503 | United States |
| BC-3781 Study Center 004 | Butte | Montana | 59701 | United States |
| BC-3781 Study Center 016 | Somers Point | New Jersey | 08244 | United States |
| FG002 | Vancomycin | Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | BC-3781 Dose 100mg | BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| BG001 | BC-3781 Dose 150mg | BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| BG002 | Vancomycin | Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Diabetic Status | Count of Participants | Participants |
| ||||||||||||||||
| Smoking Status | 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 | Clinical Response | Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required. | Clinically Evaluable Population: A subset of all randomized patients who met additional pre-defined criteria. | Posted | Count of Participants | Participants | Test of Cure (TOC), 7 - 14 days post final treatment |
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| ||||||||||||||||||||||||||||||||||
| Primary | Clinical Response | Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required | Modified Intent-to-Treat Population: A subset of the Intent-to Treat Population who had a documented Gram-positive pathogen from a blood culture or from a culture of the acute bacterial skin and skin structure infection at baseline. | Posted | Count of Participants | Participants | Test of Cure (TOC), 7 - 14 days post final treatment |
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Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant.
Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.
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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 | BC-3781 Dose 100mg | BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. | 0 | 70 | 1 | 70 | 50 | 70 |
| EG001 | BC-3781 Dose 150mg | BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. | 0 | 71 | 2 | 71 | 48 | 71 |
| EG002 | Vancomycin | Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. | 0 | 66 | 2 | 66 | 49 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Infusion Site Phlebitis | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Pruritus Generalized | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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All data from the study is confidential information. Sponsor has the right to publish first. Thereafter, PI may publish data from the study, but PI must submit the publication to Sponsor for review at least 60 days prior to publication. Sponsor may remove any confidential and/or proprietary information. If Sponsor's publication is not submitted within 12 months after the study, or if Sponsor decides not to publish, PI may publish the data, subject to Sponsor's rights in the agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Schranz, M.D., Chief Medical Officer | Nabriva Therapeutics | 610-981-2842 | jennifer.schranz@nabriva.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000591018 | lefamulin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Between 18 and 65 years |
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| >=65 years |
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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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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-diabetic |
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| Past Smoker |
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| Non-Smoker |
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| Units |
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| Counts |
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| Participants |
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