Phase 2
N=121
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
Staphylococcus Aureus Bacteremia · Staphylococcus Aureus Endocarditis
Bottom Line
View on ClinicalTrials.gov: NCT03163446 ↗Enrolled (actual)
121
Serious AEs
61.3%
Results posted
Oct 2021
Primary outcome: Primary: Incidence of Adverse Events [Safety and Tolerability] — 48; 30; 64; 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CF-301 (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ContraFect
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events [Safety and Tolerability] |
48; 30; 64; 40; 67; 40 | — |
| PRIMARY Clinical Outcome at Day 14 |
50; 27; 18; 13; 3; 5 | 0.3137 |
| PRIMARY CF-301 Maximum Plasma Concentration (Cmax) |
1450.33 | — |
| PRIMARY CF-301 Area Under the Curve (AUC 0-t) |
5667.42 | — |
| SECONDARY Clinical Outcome at Day 7 |
51; 31; 17; 11; 3; 3 | — |
| SECONDARY Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT) |
44; 28; 22; 13; 5; 4 | — |
| SECONDARY Clinical Outcome at Test of Cure (TOC) |
39; 24; 25; 15; 7; 6 | — |
| SECONDARY Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration |
59; 39; 7; 2; 3; 2 | — |
| SECONDARY Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration |
64; 38; 4; 2; 2; 3 | — |
| SECONDARY Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT) |
50; 31; 0; 2; 16; 8 | — |
| SECONDARY Microbiological Eradication at Test of Cure (TOC) |
46; 31; 0; 0; 18; 9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03163446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.