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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2016-003059-31-CZ
• Date of registration: 02/10/2017
• Prospective Registration: Yes
• Primary sponsor: ContraFect Corporation
• Public title: 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
• Scientific 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 Right-Sided Endocarditis
• Date of first enrolment: 31/10/2017
• Target sample size: 115
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003059-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Development Corporation
• Affiliation: ContraFect Corporation

• Name: Clinical Development Corporation
• Affiliation: ContraFect Corporation

Key inclusion & exclusion 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 right-sided 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:
• 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 left-sided 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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 infestations
MedDRA version: 20.1 Level: PT Classification code 10003997 Term: Bacteraemia System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1 Level: LLT Classification code 10041937 Term: Staphylococcus aureus endocarditis System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0 Level: LLT Classification code 10021839 Term: Infection MRSA System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0 Level: LLT Classification code 10054637 Term: Staphylococcal bacteremia System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Code: CF-301
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Exebacase
CAS Number: 1404122-92-4
Current Sponsor code: CF-301
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-+/- 1.0
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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

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

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 right-sided endocarditis.
• To estimate clinical outcome at Day 14 after CF 301/placebo administration.
• To describe the PK parameters of CF-301.

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

Secondary Outcome(s)

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)

Secondary ID(s)

CF-301-102

2016-003059-31-BG

Source(s) of Monetary Support

ContraFect Corporation

Ethics review

Status: Approved
Approval date:
Contact: