Clinical trial NCT03163446: Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
Official title: A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia) Including Endocarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Endocarditis
Keywords: Staphylococcus aureus
bacteremia
staphylococcal endocarditis
Lead sponsor: ContraFect
Sponsor class: INDUSTRY
First posted: 2017-05-23
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events [Safety and Tolerability]
timeFrame: Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
measure: Clinical Outcome at Day 14
timeFrame: Day 14
measure: CF-301 Maximum Plasma Concentration (Cmax)
timeFrame: 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: CF-301 Area Under the Curve (AUC 0-t)
timeFrame: 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 outcomes:
measure: Clinical Outcome at Day 7
timeFrame: Day 7
measure: Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)
timeFrame: EOT between 28-42 days
measure: Clinical Outcome at Test of Cure (TOC)
timeFrame: TOC between 56-70 days
measure: Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration
timeFrame: Day 7
measure: Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration
timeFrame: Day 14
measure: Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
timeFrame: EOT between 28-42 days
measure: Microbiological Eradication at Test of Cure (TOC)
timeFrame: TOC between 56-70 days
Other outcomes:
measure: Clinical Outcome at Day 14 in MRSA Subgroup
timeFrame: Day 14
Locations:
city: Birmingham
country: United States
facility: CF-301-102 Study Site
state: Alabama
city: Sacramento
country: United States
facility: CF-301-102 Study Site
state: California
city: Sylmar
country: United States
facility: CF301-102 Study Site
state: California
city: New Haven
country: United States
facility: CF-301-102 Study Site
state: Connecticut
city: Newark
country: United States
facility: CF-301-102 Study Site
state: Delaware
city: Atlanta
country: United States
facility: CF-301-102 Study Site
state: Georgia
city: Augusta
country: United States
facility: CF-301-102 Study Site
state: Georgia
city: Decatur
country: United States
facility: CF0301-102 Study Site
state: Georgia
city: Idaho Falls
country: United States
facility: CF-301 Study Site
state: Idaho
city: Chicago
country: United States
facility: CF301-102 Study Site
state: Illinois
city: Burlington
country: United States
facility: CF301-102 Study Site
state: Massachusetts
city: Detroit
country: United States
facility: CF-301-102 Study Site
state: Michigan
city: Royal Oak
country: United States
facility: CF301-102 Study Site
state: Michigan
city: Saint Louis
country: United States
facility: CF301-102 Study Site
state: Missouri
city: Butte
country: United States
facility: CF301-102 Study site
state: Montana
city: Omaha
country: United States
facility: CF301-102 Study Site
state: Nebraska
city: Omaha
country: United States
facility: CF-301-102 Study Site
state: Nebraska
city: Englewood
country: United States
facility: CF-301-102 Study Site
state: New Jersey
city: Paterson
country: United States
facility: CF301-102 Study Site
state: New Jersey
city: New York
country: United States
facility: CF-301-102 Study Site
state: New York
city: New York
country: United States
facility: CF-301-102 Study Site
state: New York
city: Valhalla
country: United States
facility: CF-301-102 Study Site
state: New York
city: Cleveland
country: United States
facility: CF-301-102 Study Site
state: Ohio
city: Columbus
country: United States
facility: CF301-102 Study Site
state: Ohio
city: Columbus
country: United States
facility: Cf-301-102
state: Ohio
city: Toledo
country: United States
facility: CF-301 Study Site
state: Ohio
city: Bethlehem
country: United States
facility: CF-301-102 Study Site
state: Pennsylvania
city: Richmond
country: United States
facility: Cf-301-102
state: Virginia
city: Roanoke
country: United States
facility: CF-301-102 Study Site
state: Virginia
city: Seattle
country: United States
facility: CF-301-102 Study Site
state: Washington
city: Milwaukee
country: United States
facility: CF-301-102 Study Site
state: Wisconsin
city: Brussels
country: Belgium
facility: CF-301-102 Study Site #2
city: Brussels
country: Belgium
facility: CF301-102 Study Site
city: Edegem
country: Belgium
facility: CF301-102 Study Site
city: Ghent
country: Belgium
facility: CF301-102 Study Site
city: Leuven
country: Belgium
facility: CF301-102 Study Site
city: Ruse
country: Bulgaria
facility: CF301-102 Study Site
city: Sofia
country: Bulgaria
facility: CF301-102 Study Site
city: Santiago
country: Chile
facility: CF-301-102 Study Site
city: Viña Del Mar
country: Chile
facility: CF-301-102 Study Site
city: Brno
country: Czechia
facility: CF301-102 Study Site
city: Prague
country: Czechia
facility: CF301-102 Study Site #2
city: Prague
country: Czechia
facility: CF301-102 Study Site
city: Limoges
country: France
facility: CF301-102 Study Site
city: Lyon
country: France
facility: CF301-102 Study Site
city: Paris
country: France
facility: CF301-102 Study Site
city: Toulon
country: France
facility: CF301-102 Study Site
city: Berlin
country: Germany
facility: CF-301-102 Study Site #2
city: Berlin
country: Germany
facility: CF-301-102 Study Site
city: Cologne
country: Germany
facility: CF-301-102 Study Site
city: Freiburg
country: Germany
facility: CF-301-102 Study Site
city: Athens
country: Greece
facility: CF301-102 Study Site #3
city: Athens
country: Greece
facility: CF301-102 Study Site
city: Athens
country: Greece
facility: Study Site #2
city: Larissa
country: Greece
facility: CF301-102 Study Site
city: Guatemala City
country: Guatemala
facility: CF-301-102 Study Site
city: Santa Rosita
country: Guatemala
facility: CF-301-102 Study Site
city: Be'er Sheva
country: Israel
facility: CF301-102 Study Site
city: Nazareth
country: Israel
facility: CF301-102 Study Site
city: Safed
country: Israel
facility: CF301-102 Study Site
city: Tel HaShomer
country: Israel
facility: CF301-102 Study Site
city: Bergamo
country: Italy
facility: CF301-102 Study Site
city: Busto Arsizio
country: Italy
facility: CF-301-102 Study Site
city: Genoa
country: Italy
facility: CF-301-102 Study Site
city: Krasnodar
country: Russian Federation
facility: CF-301-102 Study Site
city: Moscow
country: Russian Federation
facility: CF-301-102 Study Site
city: St. Pertersburg
country: Russian Federation
facility: CF-301-102 Study Site
city: St. Petersburg
country: Russian Federation
facility: CF-301-102 Study Site #2
city: Barcellona
country: Spain
facility: Cf301-102
city: Barcelona
country: Spain
facility: CF-301-102 Study Site #2
city: Córdoba
country: Spain
facility: CF301-102 Study Site
city: Seville
country: Spain
facility: CF301-102 Study Site
city: Terrassa
country: Spain
facility: CF301-102 Study Site
city: Chelmsford
country: United Kingdom
facility: CF301-102 Study Site
city: Liverpool
country: United Kingdom
facility: CF301-102 Study Site
city: London
country: United Kingdom
facility: CF-301-102 Study Site
city: London
country: United Kingdom
facility: CF301-102 Study Site #2
city: Oxford
country: United Kingdom
facility: CF301-102 Study Site
Study officials:
References:
citation: 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.