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The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia.
CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF-301 | Experimental | Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
|
| Placebo | Placebo Comparator | Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CF-301 | Biological | CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability] | Number and percentage of patients with treatment-emergent adverse events (TEAEs) | Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180 |
| Clinical Outcome at Day 14 | Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | Day 14 |
| CF-301 Maximum Plasma Concentration (Cmax) | CF-301 plasma concentrations at specified timepoints. | Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion |
| CF-301 Area Under the Curve (AUC 0-t) | CF-301 plasma concentrations at specified time points | Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome at Day 7 | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome at Day 14 in MRSA Subgroup | Description of clinical outcome in the MRSA subgroup in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CF-301-102 Study Site | Birmingham | Alabama | 35233 | United States | ||
| CF-301-102 Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32271718 | Derived | Fowler VG Jr, Das AF, Lipka-Diamond J, Schuch R, Pomerantz R, Jauregui-Peredo L, Bressler A, Evans D, Moran GJ, Rupp ME, Wise R, Corey GR, Zervos M, Douglas PS, Cassino C. Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis. J Clin Invest. 2020 Jul 1;130(7):3750-3760. doi: 10.1172/JCI136577. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CF-301 | Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
| FG001 | Placebo | Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2018 |
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| Placebo |
| Drug |
Placebo, given as a single 2 hour iv infusion |
|
| Day 7 |
| Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | EOT between 28-42 days |
| Clinical Outcome at Test of Cure (TOC) | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | TOC between 56-70 days |
| Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Number and percentage of patients with clearance of bacteremia in the mITT population | Day 7 |
| Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Number and percentage of patients with clearance of bacteremia in the mITT population | Day 14 |
| Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Number and percentage of patients with microbiological eradication in the mITT population | EOT between 28-42 days |
| Microbiological Eradication at Test of Cure (TOC) | Number and percentage of patients with microbiological eradication in the mITT population | TOC between 56-70 days |
| Day 14 |
| Sacramento |
| California |
| 95817 |
| United States |
| CF301-102 Study Site | Sylmar | California | 91342 | United States |
| CF-301-102 Study Site | New Haven | Connecticut | 06511 | United States |
| CF-301-102 Study Site | Newark | Delaware | 19713 | United States |
| CF-301-102 Study Site | Atlanta | Georgia | 30322 | United States |
| CF-301-102 Study Site | Augusta | Georgia | 30912 | United States |
| CF0301-102 Study Site | Decatur | Georgia | 30033 | United States |
| CF-301 Study Site | Idaho Falls | Idaho | 83404 | United States |
| CF301-102 Study Site | Chicago | Illinois | 60637 | United States |
| CF301-102 Study Site | Burlington | Massachusetts | 01805 | United States |
| CF-301-102 Study Site | Detroit | Michigan | 48201 | United States |
| CF301-102 Study Site | Royal Oak | Michigan | 48073 | United States |
| CF301-102 Study Site | St Louis | Missouri | 63110 | United States |
| CF301-102 Study site | Butte | Montana | 59701 | United States |
| CF301-102 Study Site | Omaha | Nebraska | 68131 | United States |
| CF-301-102 Study Site | Omaha | Nebraska | 68198 | United States |
| CF-301-102 Study Site | Englewood | New Jersey | 07631 | United States |
| CF301-102 Study Site | Paterson | New Jersey | 07102 | United States |
| CF-301-102 Study Site | New York | New York | 10029 | United States |
| CF-301-102 Study Site | New York | New York | 10065 | United States |
| CF-301-102 Study Site | Valhalla | New York | 10595 | United States |
| CF-301-102 Study Site | Cleveland | Ohio | 44106 | United States |
| CF301-102 Study Site | Columbus | Ohio | 43210 | United States |
| Cf-301-102 | Columbus | Ohio | 43215 | United States |
| CF-301 Study Site | Toledo | Ohio | 43608 | United States |
| CF-301-102 Study Site | Bethlehem | Pennsylvania | 18015 | United States |
| Cf-301-102 | Richmond | Virginia | 23298 | United States |
| CF-301-102 Study Site | Roanoke | Virginia | 24014 | United States |
| CF-301-102 Study Site | Seattle | Washington | 98195 | United States |
| CF-301-102 Study Site | Milwaukee | Wisconsin | 53226 | United States |
| CF-301-102 Study Site #2 | Brussels | Belgium |
| CF301-102 Study Site | Brussels | Belgium |
| CF301-102 Study Site | Edegem | Belgium |
| CF301-102 Study Site | Ghent | Belgium |
| CF301-102 Study Site | Leuven | Belgium |
| CF301-102 Study Site | Rousse | Bulgaria |
| CF301-102 Study Site | Sofia | Bulgaria |
| CF-301-102 Study Site | Santiago | Chile |
| CF-301-102 Study Site | Viña del Mar | Chile |
| CF301-102 Study Site | Brno | Czechia |
| CF301-102 Study Site #2 | Prague | Czechia |
| CF301-102 Study Site | Prague | Czechia |
| CF301-102 Study Site | Limoges | France |
| CF301-102 Study Site | Lyon | France |
| CF301-102 Study Site | Paris | France |
| CF301-102 Study Site | Toulon | France |
| CF-301-102 Study Site #2 | Berlin | Germany |
| CF-301-102 Study Site | Berlin | Germany |
| CF-301-102 Study Site | Cologne | Germany |
| CF-301-102 Study Site | Freiburg im Breisgau | Germany |
| CF301-102 Study Site #3 | Athens | Greece |
| CF301-102 Study Site | Athens | Greece |
| Study Site #2 | Athens | Greece |
| CF301-102 Study Site | Larissa | Greece |
| CF-301-102 Study Site | Guatemala City | Guatemala |
| CF-301-102 Study Site | Santa Rosita | Guatemala |
| CF301-102 Study Site | Beersheba | Israel |
| CF301-102 Study Site | Nazareth | Israel |
| CF301-102 Study Site | Safed | Israel |
| CF301-102 Study Site | Tel Litwinsky | Israel |
| CF301-102 Study Site | Bergamo | Italy |
| CF-301-102 Study Site | Busto Arsizio | Italy |
| CF-301-102 Study Site | Genoa | Italy |
| CF-301-102 Study Site | Krasnodar | Russia |
| CF-301-102 Study Site | Moscow | Russia |
| CF-301-102 Study Site | Saint Pertersburg | Russia |
| CF-301-102 Study Site #2 | Saint Petersburg | Russia |
| CF-301-102 Study Site #2 | Barcelona | Spain |
| Cf301-102 | Barcelona | Spain |
| CF301-102 Study Site | Córdoba | Spain |
| CF301-102 Study Site | Seville | Spain |
| CF301-102 Study Site | Terrassa | Spain |
| CF301-102 Study Site | Chelmsford | United Kingdom |
| CF301-102 Study Site | Liverpool | United Kingdom |
| CF-301-102 Study Site | London | United Kingdom |
| CF301-102 Study Site #2 | London | United Kingdom |
| CF301-102 Study Site | Oxford | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population
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| ID | Title | Description |
|---|---|---|
| BG000 | CF-301 | Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
| BG001 | Placebo | Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Diagnosis | 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 | Incidence of Adverse Events [Safety and Tolerability] | Number and percentage of patients with treatment-emergent adverse events (TEAEs) | Safety population | Posted | Count of Participants | Participants | Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Clinical Outcome at Day 14 | Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | Microbiological Intent-to-Treat (mITT) population | Posted | Count of Participants | Participants | Day 14 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | CF-301 Maximum Plasma Concentration (Cmax) | CF-301 plasma concentrations at specified timepoints. | PK Population (patients with serial PK samples) | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | CF-301 Area Under the Curve (AUC 0-t) | CF-301 plasma concentrations at specified time points | PK Population (patients with serial PK samples) | Posted | Mean | Standard Deviation | ng*hr/mL | Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Outcome at Day 7 | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | mITT population | Posted | Count of Participants | Participants | Day 7 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | mITT population | Posted | Count of Participants | Participants | EOT between 28-42 days |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Outcome at Test of Cure (TOC) | Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | mITT population | Posted | Count of Participants | Participants | TOC between 56-70 days |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Number and percentage of patients with clearance of bacteremia in the mITT population | mITT population | Posted | Count of Participants | Participants | Day 7 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Number and percentage of patients with clearance of bacteremia in the mITT population | mITT population | Posted | Count of Participants | Participants | Day 14 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Number and percentage of patients with microbiological eradication in the mITT population | mITT population | Posted | Count of Participants | Participants | EOT between 28-42 days |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Eradication at Test of Cure (TOC) | Number and percentage of patients with microbiological eradication in the mITT population | mITT population | Posted | Count of Participants | Participants | TOC between 56-70 days |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Clinical Outcome at Day 14 in MRSA Subgroup | Description of clinical outcome in the MRSA subgroup in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | Microbiological Intent-to-Treat (mITT) population | Posted | Count of Participants | Participants | Day 14 |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Clinical Responders at Day 14 in Patients With cBSI/R-IE | Description of clinical responder at Day 14 in patients with complicated bloodstream infection (cBSI) / right-sided endocarditis (R-IE) (excluding left-sided endocarditis) in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus. | mITT population | Posted | Count of Participants | Participants | Day 14 |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Health Resource Utilization: Length of Hospital Stay | Length of hospital stay in patients enrolled in the United States in the MRSA Subgroup in the mITT population | Microbiological Intent-to-Treat (mITT) population | Posted | Median | Full Range | days | From study drug dosing to hospital discharge (in patients discharged alive) through Day 180 |
|
| ||||||||||||||||||||||||||||||||||||
| Post-Hoc | All-cause Mortality at Day 30 in MRSA Subgroup | 30-day all-cause mortality in the MRSA subgroup in the mITT | Microbiological Intent-to-Treat (mITT) population | Posted | Count of Participants | Participants | Day 30 |
|
|
All AEs and SAEs were collected during the core study, from the time of consent through Test of Cure (TOC) between 56-70 days. After completion of the core study, all SAEs were collected during the long-term follow-up through Day 180.
All-cause mortality is reported in the intent-to-treat (ITT) population. Serious adverse events and other (not including serious) adverse events are reported in the Safety population.
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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 | CF-301 | Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. | 17 | 73 | 45 | 72 | 62 | 72 |
| EG001 | Placebo | Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. | 9 | 48 | 28 | 47 | 39 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Splenic artery thrombosis | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Impaired hearing | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Impaired self-care | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Staphylococcal bacteremia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Abscess bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Localized infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Necrotizing fasciitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Klebsiella bacteremia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ischemic cardiomyopathy | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrointestinal ulcer hemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hemorrhage intracranial | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
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| Acute graft versus host disease | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Procedure hemorrhage | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA (19.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Patient dissatisfaction with treatment | Social circumstances | MedDRA (19.1) | Systematic Assessment |
| |
| Death NOS | General disorders | MedDRA (19.1) | Systematic Assessment | Deaths recorded only on the Vital Status form were considered to have a fatal SAE of "death NOS", where NOS was not otherwise specified (for both the system organ class and preferred term). |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Eye disorders | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
After multi-center publication has been published by sponsor, or if it hasn't been published in 24 months following completion of Clinical Study Report, PI may publish results independently. PI must allow sponsor at least 90 days to review submission, to request deletion of sponsor confidential information (not study results) and in that initial 90 day period, allow delay of up to 60 additional days to allow sponsor to protect its rights to any confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | ContraFect | 914-207-2300 | clinicalstudies@contrafect.com |
| Jul 21, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705809 | exebacase |
Not provided
Not provided
Not provided
| >=65 years |
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| Male |
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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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| United Kingdom |
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| Russia |
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| Greece |
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| Belgium |
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| Guatemala |
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| Italy |
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| Israel |
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| Chile |
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| France |
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| Germany |
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| Left-sided endocarditis |
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| Right and left-sided endocarditis |
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| Uncomplicated bloodstream infection (BSI) |
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| Complicated bloodstream infection (BSI) |
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| TEAE through Day 180 |
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