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The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.
The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delafloxacin | Experimental | Delafloxacin 300 mg IV Q12H for 6 doses, then Delafloxacin 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total |
|
| Vancomycin plus Aztreonam | Active Comparator | Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delafloxacin | Drug |
|
| |
| vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge. | A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug. | 48 to 72 hrs after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [EMA] Primary Endpoint) | A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis. A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator.
Women who are pregnant or lactating.
Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely compromised immune system, severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures.
Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of the following was documented:
Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of < 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Sue K Cammarata, MD | Melinta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melinta 303 Study Site | Mobile | Alabama | 36607 | United States | ||
| Melinta 303 Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30349845 | Derived | Lodise T, Corey R, Hooper D, Cammarata S. Safety of Delafloxacin: Focus on Adverse Events of Special Interest. Open Forum Infect Dis. 2018 Sep 10;5(10):ofy220. doi: 10.1093/ofid/ofy220. eCollection 2018 Oct. | |
| 29518178 | Derived | O'Riordan W, McManus A, Teras J, Poromanski I, Cruz-Saldariagga M, Quintas M, Lawrence L, Liang S, Cammarata S; PROCEED Study Group. A Comparison of the Efficacy and Safety of Intravenous Followed by Oral Delafloxacin With Vancomycin Plus Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Multinational, Double-Blind, Randomized Study. Clin Infect Dis. 2018 Aug 16;67(5):657-666. doi: 10.1093/cid/ciy165. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Delafloxacin | 300 mg IV Q12H for 6 doses, 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total |
| FG001 | Vancomycin Plus Aztreonam | Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
|
| aztreonam | Drug |
|
| Study Day 14 ± 1 |
| Investigator-assessed Response of Signs and Symptoms of Infection at the Late Follow-up Visit | A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis. A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing). | Study Day 21 to 28 |
| Montgomery |
| Alabama |
| United States |
| Melinta 303 Study Site | Anaheim | California | United States |
| Melinta 303 Study Site | Chula Vista | California | 91911 | United States |
| Melinta 303 Study Site | La Mesa | California | 91942 | United States |
| Melinta 303 Study Site | Long Beach | California | United States |
| Melinta 303 Study Site | Modesto | California | United States |
| Melinta 303 Study Site | Oceanside | California | 92056 | United States |
| Melinta 303 Study Site | San Diego | California | 92114 | United States |
| Melinta 303 Study Site | Stockton | California | United States |
| Melinta 303 Study Site | Torrance | California | 90509 | United States |
| Melinta 303 Study Site | DeLand | Florida | United States |
| Melinta 303 Study Site | Orlando | Florida | United States |
| Melinta 303 Study Site | Columbus | Georgia | 31904 | United States |
| Melinta 303 Study Site | Savannah | Georgia | 31405 | United States |
| Melinta 303 Study Site | Eunice | Louisiana | 70535 | United States |
| Melinta 303 Study Site | Springfield | Massachusetts | United States |
| Melinta 303 Study Site | Minneapolis | Minnesota | 55422 | United States |
| Melinta 303 Study Site | Butte | Montana | United States |
| Melinta 303 Study Site | Lincoln | Nebraska | United States |
| Melinta 303 Study Site | Las Vegas | Nevada | 89109 | United States |
| Melinta 303 Study Site | Somers Point | New Jersey | 08244 | United States |
| Melinta 303 Study Site | Teaneck | New Jersey | United States |
| Melinta 303 Study Site | Columbus | Ohio | United States |
| Melinta 303 Study Site | Toledo | Ohio | United States |
| Melinta 303 Study Site | Rapid City | South Dakota | United States |
| Melinta 303 Study Site | Jackson | Tennessee | United States |
| Melinta 303 Study Site | Smyrna | Tennessee | United States |
| Melinta 303 Study Site | Channelview | Texas | 77530 | United States |
| Melinta 303 Study Site | Houston | Texas | 77024 | United States |
| Melinta 303 Study Site | San Antonio | Texas | United States |
| Melinta 303 Study Site | La Plata | Buenos Aires | Argentina |
| Melinta 303 Study Site | Rosario | Santa Fe Province | Argentina |
| Melinta 303 Study Site | Córdoba | Argentina |
| Melinta 303 Study Site | Santa Fe | Argentina |
| Melinta 303 Study Site | Salvador | Estado de Bahia | Brazil |
| Melinta 303 Study Site | Belo Horizonte | Minas Gerais | Brazil |
| Melinta 303 Study Site | Lavras | Minas Gerais | Brazil |
| Melinta 303 Study Site | Passo Fundo | Rio Grande do Sul | Brazil |
| Melinta 303 Study Site | Campinas | São Paulo | Brazil |
| Melinta 303 Study Site | São José do Rio Preto | São Paulo | Brazil |
| Melinta 303 Study Site | São Paulo | Brazil |
| Melinta 303 Study Site | Pleven | Bulgaria |
| Melinta 303 Study Site | Plovdiv | Bulgaria |
| Melinta 303 Study Site | Rousse | Bulgaria |
| Melinta 303 Study Site | Sofia | Bulgaria |
| Melinta 303 Study Site | Varna | Bulgaria |
| Melinta 303 Study Site | Santiago | Chile |
| Melinta 303 Study Site | Temuco | Chile |
| Melinta 303 Study Site | Kohtla-Järve | Estonia |
| Melinta 303 Study Site | Tallinn | Estonia |
| Melinta 303 Study Site | Tartu | Estonia |
| Melinta 303 Study Site | Võru | Estonia |
| Melinta 303 Study Site | Batumi | Georgia |
| Melinta 303 Study Site | Kutaisi | Georgia |
| Melinta 303 Study Site | Tbilisi | Georgia |
| Melinta 303 Study Site | Zugdidi | Georgia |
| Melinta 303 Study Site | Kaposvár | Hungary |
| Melinta 303 Study Site | Kecskemét | Hungary |
| Melinta 303 Study Site | Nyíregyháza | Hungary |
| Melinta 303 Study Site | Szeged | Hungary |
| Melinta 303 Study Site | Veszprém | Hungary |
| Melinta 303 Study Site | Daugavpils | Latvia |
| Melinta 303 Study Site | Liepāja | Latvia |
| Melinta 303 Study Site | Rēzekne | Latvia |
| Melinta 303 Study Site | Riga | Latvia |
| Melinta 303 Study Site | Guadalajara | Jalisco | Mexico |
| Melinta 303 Study Site | Monterrey | Nuevo León | Mexico |
| Melinta 303 Study Site | Chisinau | Moldova |
| Melinta 303 Study Site | Trujillo | La Libertad | Peru |
| Melinta 303 Study Site | Cusco | Peru |
| Melinta 303 Study Site | Lima | Peru |
| Melinta 303 Study Site | Loreto | Peru |
| Melinta 303 Study Site | Cluj-Napoca | Cluj | Romania |
| Melinta 303 Study Site | Craiova | Dolj | Romania |
| Melinta 303 Study Site | Timișoara | Timiș County | Romania |
| Melinta 303 Study Site | Bucharest | Romania |
| Melinta 303 Study Site | Târgu Mureş | Romania |
| Melinta 303 Study Site | Banská Bystrica | Slovakia |
| Melinta 303 Study Site | Prešov | Slovakia |
| Melinta 303 Study Site | Wŏnju | Gang'weondo | South Korea |
| Melinta 303 Study Site | Ansan | Gyeonggido | South Korea |
| Melinta 303 Study Site | Goyang | Gyeonggido | South Korea |
| Melinta 303 Study Site | Daegu | South Korea |
| Melinta 303 Study Site | Daejeon | South Korea |
| Melinta 303 Study Site | Gwangju | South Korea |
| Melinta 303 Study Site | Incheon | South Korea |
| Melinta 303 Study Site | Seoul | South Korea |
| Melinta 303 Study Site | Kaohsiung City | Taiwan |
| Melinta 303 Study Site | New Taipei City | Taiwan |
| Melinta 303 Study Site | Taichung | Taiwan |
| Melinta 303 Study Site | Tainan | Taiwan |
| Melinta 303 Study Site | Taipei | Taiwan |
| Melinta 303 Study Site | Zhonghe | Taiwan |
| 28630189 | Derived | McCurdy S, Lawrence L, Quintas M, Woosley L, Flamm R, Tseng C, Cammarata S. In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00772-17. doi: 10.1128/AAC.00772-17. Print 2017 Sep. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population included all patients who were randomly assigned to treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Delafloxacin | 300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total |
| BG001 | Vancomycin Plus Aztreonam | Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total |
| 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| BMI category | Count of Participants | Participants |
| ||||||||||||||||
| Presence of diabetes | 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 | Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge. | A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug. | ITT Population | Posted | Count of Participants | Participants | 48 to 72 hrs after starting treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [EMA] Primary Endpoint) | A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis. A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing). | ITT Population | Posted | Count of Participants | Participants | Study Day 14 ± 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator-assessed Response of Signs and Symptoms of Infection at the Late Follow-up Visit | A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis. A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing). | Posted | Count of Participants | Participants | Study Day 21 to 28 |
|
Adverse event data were collected from the time the patient signed informed consent through the follow-up telephone contact 30 (+3) days after the last dose of study drug (up to 48 days).
AE data are only included for the safety population which included all patients in the ITT population who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delafloxacin | 300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total | 0 | 417 | 16 | 417 | 55 | 417 |
| EG001 | Vancomycin Plus Aztreonam | Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total | 2 | 425 | 17 | 425 | 32 | 425 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Intestinal ischemia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Systemic inflammatory response symdrome | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| ALT increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| AST increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Adenocarcinoma of the colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
Melinta has the right to first publication of results, which would be made in conjunction with the PIs from all appropriate sites. Thereafter, PIs may publish results provided the PI submits the proposed publication to Melinta for review at least 60 days prior to the date of the proposed publication. Melinta may remove any information that is considered confidential and/or proprietary. If a publication is not submitted within 12 months of study conclusion, the PI may publish results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sue Cammarata (Chief Medical Officer) | Melinta Therapeutics, Inc. | 1-844-MELINTA (1-844-635-4682) | clinicaltrials@melinta.com |
| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| D017192 | Skin Diseases, Bacterial |
| D007239 | Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C477891 | delafloxacin |
| D014640 | Vancomycin |
| D001398 | Aztreonam |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008997 | Monobactams |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| > 65 years |
|
| > 75 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| North America |
|
| Mexico |
|
| Brazil |
|
| Chile |
|
| Peru |
|
| South Korea |
|
| Taiwan |
|
| Argentina |
|
| >= 30 kg/m2 |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|