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

• ClinicalTrials.gov Identifier: NCT03163446
• Recruitment Status: Completed
• First Posted: May 23, 2017
• Last Update Posted: May 20, 2019
• Sponsor: ContraFect
• Information provided by (Responsible Party): ContraFect

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis	Biological: CF-301; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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 Endocarditis
• Actual Study Start Date: May 23, 2017
• Actual Primary Completion Date: March 7, 2019
• Actual Study Completion Date: March 7, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: CF-301; 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; CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
Placebo Comparator: Placebo; Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.	Drug: Placebo; Placebo, given as a single 2 hour iv infusion

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events [Safety and Tolerability] [ Time Frame: Up to 28 days and up to 180 days ]
   Description of incidence of adverse events
2. Clinical outcome at Day 14 (improvement, response, non-response) [ Time Frame: Day 14 ]
   Description of clinical outcome in the microbiological Intent-to-Treat (mITT) population
3. CF-301 Maximum plasma concentration (Cmax) and time to Cmax [ Time Frame: Up to 48 hours ]
   CF-301 plasma concentrations at various time points
4. CF-301 time to clearance [ Time Frame: Up to 48 hours ]
   CF-301 plasma concentrations at various time points

Secondary Outcome Measures :

1. Clinical outcome at Day 7 (improvement, response, non-response) [ Time Frame: Day 7 ]
   Description of clinical outcome in the mITT population
2. Clinical outcome at End of Standard of Care Therapy (EOT) (response, non-response) [ Time Frame: Between 28-42 days ]
   Description of clinical outcome in the mITT population
3. Clinical outcome at Test of Cure (TOC) (response, non-response) [ Time Frame: Between 56-70 days ]
   Description of clinical outcome in the mITT population
4. Clearance of bacteremia at Day 7 after CF-301/placebo administration [ Time Frame: Day 7 ]
   Number and percentage of patients with clearance of bacteremia in the mITT population
5. Clearance of bacteremia at Day 14 after CF-301/placebo administration [ Time Frame: Day 14 ]
   Number and percentage of patients with clearance of bacteremia in the mITT population
6. Microbiological eradication at end of standard-of-care antibacterial therapy (EOT) [ Time Frame: Between 28-42 days ]
   Number and percentage of patients with microbiological eradication in the mITT population
7. Microbiological eradication at test of cure (TOC) [ Time Frame: Between 56-70 days ]
   Number and percentage of patients with microbiological eradication in the mITT population

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

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.
• brain abscess or meningitis.
• community acquired pneumonia or known polymicrobial bacteremia

Contacts and Locations

  Show 78 Study Locations

Sponsors and Collaborators

ContraFect

More Information

• Responsible Party: ContraFect
• ClinicalTrials.gov Identifier: NCT03163446 History of Changes
• Other Study ID Numbers: CF-301-102
• First Posted: May 23, 2017
• Last Update Posted: May 20, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ContraFect:

Staphylococcus aureus; bacteremia; staphylococcal endocarditis

Additional relevant MeSH terms:

Bacteremia; Endocarditis; Bacterial Infections; Sepsis; Infection; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Anti-Bacterial Agents; Anti-Infective Agents