Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
NCT ID: NCT03163446
Last Updated: 2021-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2017-05-23
2019-03-07
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CF-301
Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
CF-301
CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
Placebo
Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
Placebo
Placebo, given as a single 2 hour iv infusion
Interventions
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CF-301
CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
Placebo
Placebo, given as a single 2 hour iv infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ContraFect
INDUSTRY
Responsible Party
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Locations
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CF-301-102 Study Site
Birmingham, Alabama, United States
CF-301-102 Study Site
Sacramento, California, United States
CF301-102 Study Site
Sylmar, California, United States
CF-301-102 Study Site
New Haven, Connecticut, United States
CF-301-102 Study Site
Newark, Delaware, United States
CF-301-102 Study Site
Atlanta, Georgia, United States
CF-301-102 Study Site
Augusta, Georgia, United States
CF0301-102 Study Site
Decatur, Georgia, United States
CF-301 Study Site
Idaho Falls, Idaho, United States
CF301-102 Study Site
Chicago, Illinois, United States
CF301-102 Study Site
Burlington, Massachusetts, United States
CF-301-102 Study Site
Detroit, Michigan, United States
CF301-102 Study Site
Royal Oak, Michigan, United States
CF301-102 Study Site
St Louis, Missouri, United States
CF301-102 Study site
Butte, Montana, United States
CF301-102 Study Site
Omaha, Nebraska, United States
CF-301-102 Study Site
Omaha, Nebraska, United States
CF-301-102 Study Site
Englewood, New Jersey, United States
CF301-102 Study Site
Paterson, New Jersey, United States
CF-301-102 Study Site
New York, New York, United States
CF-301-102 Study Site
New York, New York, United States
CF-301-102 Study Site
Valhalla, New York, United States
CF-301-102 Study Site
Cleveland, Ohio, United States
CF301-102 Study Site
Columbus, Ohio, United States
Cf-301-102
Columbus, Ohio, United States
CF-301 Study Site
Toledo, Ohio, United States
CF-301-102 Study Site
Bethlehem, Pennsylvania, United States
Cf-301-102
Richmond, Virginia, United States
CF-301-102 Study Site
Roanoke, Virginia, United States
CF-301-102 Study Site
Seattle, Washington, United States
CF-301-102 Study Site
Milwaukee, Wisconsin, 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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CF-301-102
Identifier Type: -
Identifier Source: org_study_id
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