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: 20.0Level: LLTClassification code 10021839Term: Infection MRSASystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10077008Term: Methicillin-sensitive Staphylococcus aureus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10003997Term: BacteraemiaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10054637Term: Staphylococcal bacteremiaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10041937Term: Staphylococcus aureus endocarditisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10014665Term: EndocarditisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-003059-31-IT
• Lead Sponsor: CONTRAFECT CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 115

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.

Study & Design

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