Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology, Infectious Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/10/2019 |
| Start Date: | May 23, 2017 |
| End Date: | March 2019 |
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
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.
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.
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
We found this trial at
31
sites
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