Study to Assess the Efficacy, Safety and Pharmacokinetics of CF-301 Compared with Placebo in addition to Standard-of-Care antibiotic therapy in Blood Infections caused by S. aureus, including heart valve infections

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003059-31-BG

Enrollment

115

Registered

2017-07-18

Start date

2017-11-02

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S. aureus bloodstream infections MedDRA version: 20.0 Level: PT Classification code 10014665 Term: Endocarditis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10077008 Term: Methicillin-sensitive Staphylococcus aureus infection System Organ Class: 10021881 - Infections and

Interventions

Product Code: CF-301 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Exebacase CAS Number: 1404122-92-4

Eligibility

Sex/Gender

All

Inclusion 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 endocarditis by Modified Duke Criteria and/or known or suspected complicated S. aureus BSI. • patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

Exclusion criteria

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. • presence of infected prosthetic joint or presence of cardiac device. • known or suspected endocarditis, brain abscess, osteomyelitis or meningitis. • pneumonia or known polymicrobial bacteremia. • patient is employed by the sponsor or investigational site or is a first degree relative of a person employed by the sponsor or investigational site; patient is institutionalized by administrative or court order.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): • Safety and tolerability of CF-301 vs placebo in addition to standard-of-care antibacterial therapy • Clinical outcome at Day 14 after CF-301/placebo administration • pharmacokinetic parameters of CF-301 ; Main Objective: • To describe the safety and tolerability of CF-301 vs. placebo in addition to SOC antibacterial therapy for the treatment of patients with S. aureus BSIs including endocarditis. • To estimate clinical outcome at Day 14 after CF 301/placebo administration. • To describe the PK parameters of CF-301. ; Secondary Objective: • To estimate clinical outcome at Day 7 after CF-301/placebo administration, at the end of SOC antibacterial therapy (EOT), and at test-of-cure (TOC) 28 days after the EOT. • To estimate microbiological response at Days 7 and 14 after CF-301/placebo administration. • To estimate microbiological outcome at EOT and at TOC ; Timepoint(s) of evaluation of this end point: • Safety and tolerability of CF-301: Time of consent through test of cure • Clinical outcome at Day 14 after CF-301/placebo administration • PK parameters of CF-301: subsets of patients will give serial PK samples from either pre-dose through 48 hours, between 2.25 hours and 24 hours or 2.25 hours and 48 hours after the start of the study drug infusion	—

Measure

Time frame

Primary end point(s): • Safety and tolerability of CF-301 vs placebo in addition to standard-of-care antibacterial therapy • Clinical outcome at Day 14 after CF-301/placebo administration • pharmacokinetic parameters of CF-301 ; Main Objective: • To describe the safety and tolerability of CF-301 vs. placebo in addition to SOC antibacterial therapy for the treatment of patients with S. aureus BSIs including endocarditis. • To estimate clinical outcome at Day 14 after CF 301/placebo administration. • To describe the PK parameters of CF-301. ; Secondary Objective: • To estimate clinical outcome at Day 7 after CF-301/placebo administration, at the end of SOC antibacterial therapy (EOT), and at test-of-cure (TOC) 28 days after the EOT. • To estimate microbiological response at Days 7 and 14 after CF-301/placebo administration. • To estimate microbiological outcome at EOT and at TOC ; Timepoint(s) of evaluation of this end point: • Safety and tolerability of CF-301: Time of consent through test of cure • Clinical outcome at Day 14 after CF-301/placebo administration • PK parameters of CF-301: subsets of patients will give serial PK samples from either pre-dose through 48 hours, between 2.25 hours and 24 hours or 2.25 hours and 48 hours after the start of the study drug infusion

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Secondary

Measure	Time frame
Secondary end point(s): • Clinical outcome at Day 7 after CF301/placebo administration • Clinical outcome at the end of SOC antibacterial therapy (EOT), and at test of cure (TOC), and 28 days after EOT • Microbiological response • Microbiological outcome ; Timepoint(s) of evaluation of this end point: • Clinical outcome: at Day 7 after CF-301/placebo administration, end of standard of care antibacterial therapy (EOT), at test of cure, 28 days after end of standard of care therapy • Microbiological response: at Days 7 and 14 after CF-301/placebo administration • Microbiological outcome at End of therapy and Test of cure (28 days after end of therapy)	—

Measure

Time frame

Secondary end point(s): • Clinical outcome at Day 7 after CF301/placebo administration • Clinical outcome at the end of SOC antibacterial therapy (EOT), and at test of cure (TOC), and 28 days after EOT • Microbiological response • Microbiological outcome ; Timepoint(s) of evaluation of this end point: • Clinical outcome: at Day 7 after CF-301/placebo administration, end of standard of care antibacterial therapy (EOT), at test of cure, 28 days after end of standard of care therapy • Microbiological response: at Days 7 and 14 after CF-301/placebo administration • Microbiological outcome at End of therapy and Test of cure (28 days after end of therapy)

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Countries

Argentina, Belgium, Bulgaria, Chile, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Russian Federation, Spain, United Kingdom, United States

Contacts

Public ContactClinical Development Corporation

ContraFect Corporation

clinicalstudies@contrafect.com+1914207 2300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026