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The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delafloxacin | Drug | 300 mg intravenous every 12 hours |
| |
| delafloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry. | 14-21 days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) | A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne Breen, MD | Melinta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physician Alliance Research Center | Anaheim | California | United States | |||
| Quality of Life Medical Center, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25448332 | Derived | O'Riordan W, Mehra P, Manos P, Kingsley J, Lawrence L, Cammarata S. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30. |
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This study targeted participants with complicated skin and skin structure infections (cSSSI), i.e. infections involving subcutaneous tissues or requiring surgical intervention. Patients could have one of three infection types: wound infection, abscess, or cellulitis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delafloxacin 300 mg IV q12h | |
| FG001 | Delafloxacin 450 mg IV q12h | |
| FG002 | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
450 mg intravenous every 12 hours |
|
| tigecycline | Drug | 100 mg then 50 mg intravenous tigecycline every 12 hours |
|
| 14-21 days after the last dose of study drug |
| Hawaiian Gardens |
| California |
| United States |
| Tri City Medical Center | Oceanside | California | United States |
| Crest Clinical Trials | Santa Ana | California | United States |
| Internal Medicine Associates of Lee County | Fort Myers | Florida | United States |
| Joseph M. Still Research Foundation, Inc. | Augusta | Georgia | United States |
| Southeast Regional Research Group | Columbus | Georgia | United States |
| Southeast Regional Research Group | Ludowici | Georgia | United States |
| Southeast Regional Research Group | Savannah | Georgia | United States |
| St. James Health Care | Butte | Montana | United States |
| Riverside Methodist Hospital | Columbus | Ohio | United States |
| West Houston Clinical Research Services | Houston | Texas | United States |
| Westbury Medical Clinic | Houston | Texas | United States |
| Clinical Research Puerto Rico, Inc | San Juan | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Delafloxacin 300 mg IV q12h | |
| BG001 | Delafloxacin 450 mg IV q12h | |
| BG002 | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h | |
| BG003 | 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 |
|
| 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 at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry. | The CE population included patients with a diagnosis of cSSSI who received at least 80% of study drug, had a test of cure (TOC) visit 14-21 days after the last dose of study drug, and who did not receive any concomitant, systemic antibacterial therapy with activity against the causative pathogen. | Posted | Number | Participants | 14-21 days after the last dose of study drug |
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| Secondary | Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) | A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry. | Clinically Evaluable (CE) patients (see previous definition) with MRSA isolated from screening culture of primary infection. | Posted | Number | Participants | 14-21 days after the last dose of study drug |
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All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
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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 | Delafloxacin 300 mg IV q12h | 1 | 49 | 14 | 49 | |||
| EG001 | Delafloxacin 450 mg IV q12h | 3 | 51 | 32 | 51 | |||
| EG002 | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h | 3 | 50 | 36 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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The sponsor retains control of all publication rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugene Sun, M.D. | Melinta Therapeutics | 203.624.5606 | esun@melinta.com |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D013207 | Staphylococcal Skin 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 |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| C477891 | delafloxacin |
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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