Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

NCT03163446 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CF-301-102
• Study Type: interventional
• Target: 121
• Locations: 14 countries
• Sites: 78

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.

Conditions

Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis

Keywords

Staphylococcus aureus; bacteremia; staphylococcal endocarditis

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• Clinical Outcome at Day 7

  Day 7

• Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)

  EOT between 28-42 days

• Clinical Outcome at Test of Cure (TOC)

  TOC between 56-70 days

• Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration

  Day 7

• Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration

  Day 14

Other Outcomes (1)

• Clinical Outcome at Day 14 in MRSA Subgroup

  Day 14

Study Arms (2)

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.

Biological: CF-301

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.

Drug: Placebo

Interventions

CF-301 BIOLOGICAL

CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion

CF-301

Placebo DRUG

Placebo, given as a single 2 hour iv infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ContraFect: lead

Study Sites (78)

CF-301-102 Study Site

Birmingham, Alabama, 35233, United States

Location

CF-301-102 Study Site

Sacramento, California, 95817, United States

Location

CF301-102 Study Site

Sylmar, California, 91342, United States

Location

CF-301-102 Study Site

New Haven, Connecticut, 06511, United States

Location

CF-301-102 Study Site

Newark, Delaware, 19713, United States

Location

CF-301-102 Study Site

Atlanta, Georgia, 30322, United States

Location

CF-301-102 Study Site

Augusta, Georgia, 30912, United States

Location

CF0301-102 Study Site

Decatur, Georgia, 30033, United States

Location

CF-301 Study Site

Idaho Falls, Idaho, 83404, United States

Location

CF301-102 Study Site

Chicago, Illinois, 60637, United States

Location

CF301-102 Study Site

Burlington, Massachusetts, 01805, United States

Location

CF-301-102 Study Site

Detroit, Michigan, 48201, United States

Location

CF301-102 Study Site

Royal Oak, Michigan, 48073, United States

Location

CF301-102 Study Site

St Louis, Missouri, 63110, United States

Location

CF301-102 Study site

Butte, Montana, 59701, United States

Location

CF301-102 Study Site

Omaha, Nebraska, 68131, United States

Location

CF-301-102 Study Site

Omaha, Nebraska, 68198, United States

Location

CF-301-102 Study Site

Englewood, New Jersey, 07631, United States

Location

CF301-102 Study Site

Paterson, New Jersey, 07102, United States

Location

CF-301-102 Study Site

New York, New York, 10029, United States

Location

CF-301-102 Study Site

New York, New York, 10065, United States

Location

CF-301-102 Study Site

Valhalla, New York, 10595, United States

Location

CF-301-102 Study Site

Cleveland, Ohio, 44106, United States

Location

CF301-102 Study Site

Columbus, Ohio, 43210, United States

Location

Cf-301-102

Columbus, Ohio, 43215, United States

Location

CF-301 Study Site

Toledo, Ohio, 43608, United States

Location

CF-301-102 Study Site

Bethlehem, Pennsylvania, 18015, United States

Location

Cf-301-102

Richmond, Virginia, 23298, United States

Location

CF-301-102 Study Site

Roanoke, Virginia, 24014, United States

Location

CF-301-102 Study Site

Seattle, Washington, 98195, United States

Location

CF-301-102 Study Site

Milwaukee, Wisconsin, 53226, United States

Location

CF-301-102 Study Site #2

Brussels, Belgium

Location

CF301-102 Study Site

Brussels, Belgium

Location

CF301-102 Study Site

Edegem, Belgium

Location

CF301-102 Study Site

Ghent, Belgium

Location

CF301-102 Study Site

Leuven, Belgium

Location

CF301-102 Study Site

Rousse, Bulgaria

Location

CF301-102 Study Site

Sofia, Bulgaria

Location

CF-301-102 Study Site

Santiago, Chile

Location

CF-301-102 Study Site

Viña del Mar, Chile

Location

CF301-102 Study Site

Brno, Czechia

Location

CF301-102 Study Site #2

Prague, Czechia

Location

CF301-102 Study Site

Prague, Czechia

Location

CF301-102 Study Site

Limoges, France

Location

CF301-102 Study Site

Lyon, France

Location

CF301-102 Study Site

Paris, France

Location

CF301-102 Study Site

Toulon, France

Location

CF-301-102 Study Site #2

Berlin, Germany

Location

CF-301-102 Study Site

Berlin, Germany

Location

CF-301-102 Study Site

Cologne, Germany

Location

CF-301-102 Study Site

Freiburg im Breisgau, Germany

Location

CF301-102 Study Site #3

Athens, Greece

Location

CF301-102 Study Site

Athens, Greece

Location

Study Site #2

Athens, Greece

Location

CF301-102 Study Site

Larissa, Greece

Location

CF-301-102 Study Site

Guatemala City, Guatemala

Location

CF-301-102 Study Site

Santa Rosita, Guatemala

Location

CF301-102 Study Site

Beersheba, Israel

Location

CF301-102 Study Site

Nazareth, Israel

Location

CF301-102 Study Site

Safed, Israel

Location

CF301-102 Study Site

Tel Litwinsky, Israel

Location

CF301-102 Study Site

Bergamo, Italy

Location

CF-301-102 Study Site

Busto Arsizio, Italy

Location

CF-301-102 Study Site

Genoa, Italy

Location

CF-301-102 Study Site

Krasnodar, Russia

Location

CF-301-102 Study Site

Moscow, Russia

Location

CF-301-102 Study Site

Saint Pertersburg, Russia

Location

CF-301-102 Study Site #2

Saint Petersburg, Russia

Location

CF-301-102 Study Site #2

Barcelona, Spain

Location

Cf301-102

Barcelona, Spain

Location

CF301-102 Study Site

Córdoba, Spain

Location

CF301-102 Study Site

Seville, Spain

Location

CF301-102 Study Site

Terrassa, Spain

Location

CF301-102 Study Site

Chelmsford, United Kingdom

Location

CF301-102 Study Site

Liverpool, United Kingdom

Location

CF-301-102 Study Site

London, United Kingdom

Location

CF301-102 Study Site #2

London, United Kingdom

Location

CF301-102 Study Site

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32271718 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Bacteremia

Interventions

exebacase

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Director
• Organization: ContraFect

clinicalstudies@contrafect.com

914-207-2300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 23, 2017
• Study Start: May 23, 2017
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: October 8, 2021
• Results First Posted: October 8, 2021

Record last verified: 2021-09

Locations

ES (5); FR (4); CZ (3); CL (2); RU (4); GR (4); IT (3); US (31); BU (2); DE (4); GU (2); BE (5); GB (5); IL (4)