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Completed

NCT Number: NCT03163446

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

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.

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Key information

Conditions

Staphylococcus Aureus Bacteremia Bacteremia Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Staphylococcal Infections Staphylococcus Aureus Endocarditis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CF-301-102 Study Site #2, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CF-301

Biological

CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion

Placebo

Drug

Placebo, given as a single 2 hour iv infusion

Primary outcomes

  1. Incidence of Adverse Events [Safety and Tolerability]

    Time frame: Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180

    Number and percentage of patients with treatment-emergent adverse events (TEAEs)

  2. Clinical Outcome at Day 14

    Time frame: Day 14

    Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.

  3. CF-301 Maximum Plasma Concentration (Cmax)

    Time frame: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion

    CF-301 plasma concentrations at specified timepoints.

  4. CF-301 Area Under the Curve (AUC 0-t)

    Time frame: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion

    CF-301 plasma concentrations at specified time points

Secondary outcomes

  1. Clinical Outcome at Day 7

    Time frame: Day 7

    Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.

  2. Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)

    Time frame: EOT between 28-42 days

    Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.

  3. Clinical Outcome at Test of Cure (TOC)

    Time frame: TOC between 56-70 days

    Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.

  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: EOT 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: TOC between 56-70 days

    Number and percentage of patients with microbiological eradication in the mITT population

Other outcomes

  1. Clinical Outcome at Day 14 in MRSA Subgroup

    Time frame: Day 14

    Description of clinical outcome in the MRSA subgroup in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.

Sponsors and collaborators

Lead sponsor

ContraFect

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 23, 2017
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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