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

Phase 1

• 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 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; MedDRA version: 20.1 Level: PT Classification code 10003997 Term: Bacteraemia System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-003059-31-GB
• Lead Sponsor: ContraFect Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 115

Inclusion Criteria

• male or female, 18 years or older.
• blood culture positive for S. aureus.
• at least two signs or symptoms 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

• 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 prosthetic cardiac valve, cardiac valve support ring, or other implantable cardiac device.
• known or suspected endocarditis, brain abscess 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified