Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Conditions
Keywords
Staphylococcus aureus, bacteremia, staphylococcal endocarditis
Brief summary
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.
Interventions
BIOLOGICALCF-301
CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
DRUGPlacebo
Placebo, given as a single 2 hour iv infusion
Sponsors
ContraFect
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female, 18 years or older * blood culture positive for S. aureus * at least one sign or symptom attributable to S. aureus bacteremia * known or suspected complicated S. aureus BSI and/or endocarditis by Modified Duke Criteria * patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential.
Exclusion criteria
* patient previously received CF-301. * treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 72 hours within 7 days before randomization. * presence of any removable infection source that will not be removed or debrided within 72 hours after randomization. * brain abscess or meningitis. * community acquired pneumonia or known polymicrobial bacteremia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CF-301 Area Under the Curve (AUC 0-t) | 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 plasma concentrations at specified time points |
| Incidence of Adverse Events [Safety and Tolerability] | Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180 | Number and percentage of patients with treatment-emergent adverse events (TEAEs) |
| Clinical Outcome at Day 14 | 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. |
| CF-301 Maximum Plasma Concentration (Cmax) | 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 plasma concentrations at specified timepoints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Day 7 | Number and percentage of patients with clearance of bacteremia in the mITT population |
| Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Day 14 | Number and percentage of patients with clearance of bacteremia in the mITT population |
| Microbiological Eradication at Test of Cure (TOC) | TOC between 56-70 days | Number and percentage of patients with microbiological eradication in the mITT population |
| Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | EOT between 28-42 days | Number and percentage of patients with microbiological eradication in the mITT population |
| Clinical Outcome at Day 7 | 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. |
| Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | EOT between 28-42 days | 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. |
| Clinical Outcome at Test of Cure (TOC) | TOC between 56-70 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome at Day 14 in MRSA Subgroup | Day 14 | 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. |
Countries
Belgium, Bulgaria, Chile, Czechia, France, Germany, Greece, Guatemala, Israel, Italy, Russia, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CF-301 Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. | 73 |
| Placebo Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. | 48 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 5 |
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | Patient randomized but went to surgery and was unable to be dosed. | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Unable to return for Day 180 visit | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | Total | Placebo | CF-301 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 12 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 36 Participants | 50 Participants |
| Age, Continuous | 55.9 years STANDARD_DEVIATION 15.39 | 55.0 years STANDARD_DEVIATION 15.62 | 56.6 years STANDARD_DEVIATION 15.24 |
| Diagnosis Complicated bloodstream infection (BSI) | 80 Participants | 37 Participants | 43 Participants |
| Diagnosis Left-sided endocarditis | 13 Participants | 3 Participants | 10 Participants |
| Diagnosis Right and left-sided endocarditis | 1 Participants | 0 Participants | 1 Participants |
| Diagnosis Right-sided endocarditis | 8 Participants | 3 Participants | 5 Participants |
| Diagnosis Uncomplicated bloodstream infection (BSI) | 16 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) White | 81 Participants | 30 Participants | 51 Participants |
| Region of Enrollment Belgium | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Chile | 2 participants | 1 participants | 1 participants |
| Region of Enrollment France | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Germany | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Greece | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Guatemala | 9 participants | 5 participants | 4 participants |
| Region of Enrollment Israel | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Italy | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Russia | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United Kingdom | 4 participants | 2 participants | 2 participants |
| Region of Enrollment United States | 96 participants | 38 participants | 58 participants |
| Sex: Female, Male Female | 39 Participants | 16 Participants | 23 Participants |
| Sex: Female, Male Male | 82 Participants | 32 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 73 | 9 / 48 |
| other Total, other adverse events | 62 / 72 | 39 / 47 |
| serious Total, serious adverse events | 45 / 72 | 28 / 47 |
Outcome results
Primary
CF-301 Area Under the Curve (AUC 0-t)
CF-301 plasma concentrations at specified time points
Time frame: 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
Population: PK Population (patients with serial PK samples)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CF-301 | CF-301 Area Under the Curve (AUC 0-t) | 5667.42 ng*hr/mL | Standard Deviation 3032.03 |
Primary
CF-301 Maximum Plasma Concentration (Cmax)
CF-301 plasma concentrations at specified timepoints.
Time frame: 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
Population: PK Population (patients with serial PK samples)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CF-301 | CF-301 Maximum Plasma Concentration (Cmax) | 1450.33 ng/mL | Standard Deviation 636.83 |
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.
Time frame: Day 14
Population: Microbiological Intent-to-Treat (mITT) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Clinical Outcome at Day 14 | Non-response | 18 Participants |
| CF-301 | Clinical Outcome at Day 14 | Responder (Improvement/Response) | 50 Participants |
| CF-301 | Clinical Outcome at Day 14 | Indeterminate | 3 Participants |
| Placebo | Clinical Outcome at Day 14 | Responder (Improvement/Response) | 27 Participants |
| Placebo | Clinical Outcome at Day 14 | Non-response | 13 Participants |
| Placebo | Clinical Outcome at Day 14 | Indeterminate | 5 Participants |
p-value: 0.313790% CI: [-6.35, 27.19]Fisher Exact
Primary
Incidence of Adverse Events [Safety and Tolerability]
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Time frame: Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Incidence of Adverse Events [Safety and Tolerability] | TEAE through Day 7 | 48 Participants |
| CF-301 | Incidence of Adverse Events [Safety and Tolerability] | TEAE through TOC | 64 Participants |
| CF-301 | Incidence of Adverse Events [Safety and Tolerability] | TEAE through Day 180 | 67 Participants |
| Placebo | Incidence of Adverse Events [Safety and Tolerability] | TEAE through Day 7 | 30 Participants |
| Placebo | Incidence of Adverse Events [Safety and Tolerability] | TEAE through TOC | 40 Participants |
| Placebo | Incidence of Adverse Events [Safety and Tolerability] | TEAE through Day 180 | 40 Participants |
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
Time frame: Day 14
Population: mITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Clearance/presumed clearance of bacteremia | 64 Participants |
| CF-301 | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Ongoing bacteremia | 4 Participants |
| CF-301 | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Presumed ongoing bacteremia | 2 Participants |
| CF-301 | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Indeterminate | 1 Participants |
| Placebo | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Indeterminate | 2 Participants |
| Placebo | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Clearance/presumed clearance of bacteremia | 38 Participants |
| Placebo | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Presumed ongoing bacteremia | 3 Participants |
| Placebo | Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration | Ongoing bacteremia | 2 Participants |
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
Time frame: Day 7
Population: mITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Clearance/presumed clearance of bacteremia | 59 Participants |
| CF-301 | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Ongoing bacteremia | 7 Participants |
| CF-301 | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Presumed ongoing bacteremia | 3 Participants |
| CF-301 | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Indeterminate | 2 Participants |
| Placebo | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Indeterminate | 2 Participants |
| Placebo | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Clearance/presumed clearance of bacteremia | 39 Participants |
| Placebo | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Presumed ongoing bacteremia | 2 Participants |
| Placebo | Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration | Ongoing bacteremia | 2 Participants |
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.
Time frame: Day 7
Population: mITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Clinical Outcome at Day 7 | Responder (Improvement/Response) | 51 Participants |
| CF-301 | Clinical Outcome at Day 7 | Non-response | 17 Participants |
| CF-301 | Clinical Outcome at Day 7 | Indeterminate | 3 Participants |
| Placebo | Clinical Outcome at Day 7 | Responder (Improvement/Response) | 31 Participants |
| Placebo | Clinical Outcome at Day 7 | Non-response | 11 Participants |
| Placebo | Clinical Outcome at Day 7 | Indeterminate | 3 Participants |
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.
Time frame: EOT between 28-42 days
Population: mITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Responder (Improvement/Response) | 44 Participants |
| CF-301 | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Non-response | 22 Participants |
| CF-301 | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Indeterminate | 5 Participants |
| Placebo | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Responder (Improvement/Response) | 28 Participants |
| Placebo | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Non-response | 13 Participants |
| Placebo | Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) | Indeterminate | 4 Participants |
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.
Time frame: TOC between 56-70 days
Population: mITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Clinical Outcome at Test of Cure (TOC) | Responder (Improvement/Response) | 39 Participants |
| CF-301 | Clinical Outcome at Test of Cure (TOC) | Non-Response | 25 Participants |
| CF-301 | Clinical Outcome at Test of Cure (TOC) | Indeterminate | 7 Participants |
| Placebo | Clinical Outcome at Test of Cure (TOC) | Responder (Improvement/Response) | 24 Participants |
| Placebo | Clinical Outcome at Test of Cure (TOC) | Non-Response | 15 Participants |
| Placebo | Clinical Outcome at Test of Cure (TOC) | Indeterminate | 6 Participants |
Secondary
Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
Number and percentage of patients with microbiological eradication in the mITT population
Time frame: EOT between 28-42 days
Population: mITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Persistence | 0 Participants |
| CF-301 | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Relapse | 0 Participants |
| CF-301 | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Presumed persistence | 16 Participants |
| CF-301 | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Indeterminate | 5 Participants |
| CF-301 | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Eradication/presumptive eradication | 50 Participants |
| Placebo | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Indeterminate | 4 Participants |
| Placebo | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Eradication/presumptive eradication | 31 Participants |
| Placebo | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Persistence | 2 Participants |
| Placebo | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Presumed persistence | 8 Participants |
| Placebo | Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) | Relapse | 0 Participants |
Secondary
Microbiological Eradication at Test of Cure (TOC)
Number and percentage of patients with microbiological eradication in the mITT population
Time frame: TOC between 56-70 days
Population: mITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Microbiological Eradication at Test of Cure (TOC) | Eradication/presumptive eradication | 46 Participants |
| CF-301 | Microbiological Eradication at Test of Cure (TOC) | Relapse | 0 Participants |
| CF-301 | Microbiological Eradication at Test of Cure (TOC) | Presumed persistence | 18 Participants |
| CF-301 | Microbiological Eradication at Test of Cure (TOC) | Indeterminate | 7 Participants |
| CF-301 | Microbiological Eradication at Test of Cure (TOC) | Persistence | 0 Participants |
| Placebo | Microbiological Eradication at Test of Cure (TOC) | Indeterminate | 5 Participants |
| Placebo | Microbiological Eradication at Test of Cure (TOC) | Eradication/presumptive eradication | 31 Participants |
| Placebo | Microbiological Eradication at Test of Cure (TOC) | Persistence | 0 Participants |
| Placebo | Microbiological Eradication at Test of Cure (TOC) | Presumed persistence | 9 Participants |
| Placebo | Microbiological Eradication at Test of Cure (TOC) | Relapse | 0 Participants |
Post Hoc
All-cause Mortality at Day 30 in MRSA Subgroup
30-day all-cause mortality in the MRSA subgroup in the mITT
Time frame: Day 30
Population: Microbiological Intent-to-Treat (mITT) population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CF-301 | All-cause Mortality at Day 30 in MRSA Subgroup | 1 Participants |
| Placebo | All-cause Mortality at Day 30 in MRSA Subgroup | 4 Participants |
p-value: 0.055690% CI: [-45.1, 2.5]Fisher Exact
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.
Time frame: Day 14
Population: Microbiological Intent-to-Treat (mITT) population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF-301 | Clinical Outcome at Day 14 in MRSA Subgroup | Responder (Improvement/Response) | 20 Participants |
| CF-301 | Clinical Outcome at Day 14 in MRSA Subgroup | Non-response | 4 Participants |
| CF-301 | Clinical Outcome at Day 14 in MRSA Subgroup | Indeterminate | 3 Participants |
| Placebo | Clinical Outcome at Day 14 in MRSA Subgroup | Responder (Improvement/Response) | 5 Participants |
| Placebo | Clinical Outcome at Day 14 in MRSA Subgroup | Non-response | 8 Participants |
| Placebo | Clinical Outcome at Day 14 in MRSA Subgroup | Indeterminate | 3 Participants |
p-value: 0.010190% CI: [14.3, 71.4]Fisher Exact
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.
Time frame: Day 14
Population: mITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CF-301 | Clinical Responders at Day 14 in Patients With cBSI/R-IE | 36 Participants |
| Placebo | Clinical Responders at Day 14 in Patients With cBSI/R-IE | 22 Participants |
p-value: 0.0646Fisher Exact
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
Time frame: From study drug dosing to hospital discharge (in patients discharged alive) through Day 180
Population: Microbiological Intent-to-Treat (mITT) population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CF-301 | Health Resource Utilization: Length of Hospital Stay | 6 days |
| Placebo | Health Resource Utilization: Length of Hospital Stay | 10 days |