Trial record 1 of 5 for:
CF-301
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 |
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Recruitment Status :
Completed
First Posted : May 23, 2017
Results First Posted : October 8, 2021
Last Update Posted : October 8, 2021
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Sponsor:
ContraFect
Information provided by (Responsible Party):
ContraFect
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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) |
| Actual Enrollment : | 121 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 |
| Actual Primary Completion Date : | March 7, 2019 |
| Actual Study Completion Date : | March 7, 2019 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Staphylococcus aureus
| Arm | Intervention/treatment |
|---|---|
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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.
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Biological: CF-301
CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion |
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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.
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Drug: Placebo
Placebo, given as a single 2 hour iv infusion |
Primary Outcome Measures :
- 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)
- 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.
- 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.
- 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 Outcome Measures :
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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 Outcome Measures:
- 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.
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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.
- brain abscess or meningitis.
- community acquired 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
Locations
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Sponsors and Collaborators
ContraFect
Study Documents (Full-Text)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ContraFect |
| ClinicalTrials.gov Identifier: | NCT03163446 |
| Other Study ID Numbers: |
CF-301-102 |
| First Posted: | May 23, 2017 Key Record Dates |
| Results First Posted: | October 8, 2021 |
| Last Update Posted: | October 8, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by ContraFect:
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Staphylococcus aureus bacteremia staphylococcal endocarditis |
Additional relevant MeSH terms:
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Staphylococcal Infections Bacteremia Endocarditis Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Heart Diseases Cardiovascular Diseases |