Staphylococcus Aureus Bacteremia Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05862025 -
Evaluation of the Usefulness of Echocardiography in Patients With Staphylococcus Aureus Bacteremia (ET-AUREUS Study).
|
N/A | |
| Not yet recruiting |
NCT05361135 -
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
|
N/A | |
| Recruiting |
NCT00622882 -
Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia
|
N/A | |
| Recruiting |
NCT06168474 -
Evaluating Simplified Layered Consent for Clinical Trials
|
N/A | |
| Not yet recruiting |
NCT06336824 -
Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia
|
Phase 3 | |
| Completed |
NCT02357966 -
A Study of the Safety and Efficacy of 514G3 in Subjects Hospitalized With Bacteremia Due to Staphylococcus Aureus
|
Phase 1/Phase 2 | |
| Terminated |
NCT03089697 -
Phase IIa Clinical Study of N-Rephasin® SAL200
|
Phase 2 | |
| Recruiting |
NCT03514446 -
Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia
|
Phase 4 | |
| Not yet recruiting |
NCT04886284 -
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
|
Phase 2 | |
| Withdrawn |
NCT03761953 -
Oritavancin for Staphylococcus Aureus Infections in Opioid Users
|
Phase 4 | |
| Recruiting |
NCT06249451 -
Staphylococcus Aureus Bacteraemia (SAB)-Support-Study
|
N/A | |
| Recruiting |
NCT02098850 -
Staphylococcus Aureus Bacteraemia in Adults
|
N/A | |
| Completed |
NCT01701219 -
Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia
|
Phase 4 | |
| Recruiting |
NCT05137119 -
Staphylococcus Aureus Network Adaptive Platform Trial
|
Phase 4 | |
| Completed |
NCT03908086 -
Bloodstream Infections in Patients With Rheumatoid Arthritis
|
||
| Terminated |
NCT04160468 -
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
|
Phase 3 | |
| Completed |
NCT03138733 -
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
|
Phase 3 | |
| Completed |
NCT02476487 -
The Benefit of FDG PET CT in the Treatment Algorithm of Staphylococcus Aureus Bacteremia
|
N/A | |
| Recruiting |
NCT05184764 -
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
|
Phase 1/Phase 2 | |
| Completed |
NCT01971762 -
Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology
|
N/A |