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

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ClinicalTrials.gov Identifier: NCT03163446
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
ContraFect

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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.
  • presence of infected prosthetic joint or presence of cardiac device
  • brain abscess, osteomyelitis or meningitis.
  • pneumonia or known polymicrobial bacteremia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163446


Contacts
Contact: Medical Director, ContraFect 914 207-2300 clinicalstudies@contrafect.com
Contact: Head of Clinical Development Operations at ContraFect 914 207-2300 clinicalstudies@contrafect.com

  Show 54 Study Locations
Sponsors and Collaborators
ContraFect

Responsible Party: ContraFect
ClinicalTrials.gov Identifier: NCT03163446     History of Changes
Other Study ID Numbers: CF-301-102
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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