Staphylococcus Aureus BacteremiaPhase 2NCT03163446
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
A Phase 2 study testing CF-301 in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Endocarditis, run by ContraFect at 78 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
- What is being tested?
- CF-301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 78 sitesin 14 countries
- Study dates
- 23 May 2017to 7 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
78 sites in 14 countries.
78 sites in 14 countries
United States31 sites
CF-301-102 Study Site
Atlanta, Georgia, 30322
CF-301-102 Study Site
Augusta, Georgia, 30912
CF-301-102 Study Site
Bethlehem, Pennsylvania, 18015
CF-301-102 Study Site
Birmingham, Alabama, 35233
CF301-102 Study Site
Burlington, Massachusetts, 01805
CF301-102 Study site
Butte, Montana, 59701
CF301-102 Study Site
Chicago, Illinois, 60637
CF-301-102 Study Site
Cleveland, Ohio, 44106
CF301-102 Study Site
Columbus, Ohio, 43210
Cf-301-102
Columbus, Ohio, 43215
CF0301-102 Study Site
Decatur, Georgia, 30033
CF-301-102 Study Site
Detroit, Michigan, 48201
CF-301-102 Study Site
Englewood, New Jersey, 07631
CF-301 Study Site
Idaho Falls, Idaho, 83404
CF-301-102 Study Site
Milwaukee, Wisconsin, 53226
CF-301-102 Study Site
New Haven, Connecticut, 06511
CF-301-102 Study Site
New York, New York, 10029
CF-301-102 Study Site
New York, New York, 10065
CF-301-102 Study Site
Newark, Delaware, 19713
CF301-102 Study Site
Omaha, Nebraska, 68131
CF-301-102 Study Site
Omaha, Nebraska, 68198
CF301-102 Study Site
Paterson, New Jersey, 07102
Cf-301-102
Richmond, Virginia, 23298
CF-301-102 Study Site
Roanoke, Virginia, 24014
CF301-102 Study Site
Royal Oak, Michigan, 48073
CF-301-102 Study Site
Sacramento, California, 95817
CF-301-102 Study Site
Seattle, Washington, 98195
CF301-102 Study Site
St Louis, Missouri, 63110
CF301-102 Study Site
Sylmar, California, 91342
CF-301 Study Site
Toledo, Ohio, 43608
CF-301-102 Study Site
Valhalla, New York, 10595
Belgium5 sites
CF-301-102 Study Site #2
Brussels
CF301-102 Study Site
Brussels
CF301-102 Study Site
Edegem
CF301-102 Study Site
Ghent
CF301-102 Study Site
Leuven
Spain5 sites
CF-301-102 Study Site #2
Barcelona
Cf301-102
Barcelona
CF301-102 Study Site
Córdoba
CF301-102 Study Site
Seville
CF301-102 Study Site
Terrassa
United Kingdom5 sites
CF301-102 Study Site
Chelmsford
CF301-102 Study Site
Liverpool
CF-301-102 Study Site
London
CF301-102 Study Site #2
London
CF301-102 Study Site
Oxford
France4 sites
CF301-102 Study Site
Limoges
CF301-102 Study Site
Lyon
CF301-102 Study Site
Paris
CF301-102 Study Site
Toulon
Germany4 sites
CF-301-102 Study Site #2
Berlin
CF-301-102 Study Site
Berlin
CF-301-102 Study Site
Cologne
CF-301-102 Study Site
Freiburg im Breisgau
Greece4 sites
CF301-102 Study Site #3
Athens
CF301-102 Study Site
Athens
Study Site #2
Athens
CF301-102 Study Site
Larissa
Israel4 sites
CF301-102 Study Site
Beersheba
CF301-102 Study Site
Nazareth
CF301-102 Study Site
Safed
CF301-102 Study Site
Tel HaShomer
Russia4 sites
CF-301-102 Study Site
Krasnodar
CF-301-102 Study Site
Moscow
CF-301-102 Study Site
Saint Pertersburg
CF-301-102 Study Site #2
Saint Petersburg
Czechia3 sites
CF301-102 Study Site
Brno
CF301-102 Study Site #2
Prague
CF301-102 Study Site
Prague
Italy3 sites
CF301-102 Study Site
Bergamo
CF-301-102 Study Site
Busto Arsizio
CF-301-102 Study Site
Genoa
Guatemala2 sites
CF-301-102 Study Site
Guatemala City
CF-301-102 Study Site
Santa Rosita
About this study
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.
- Being tested
- CF-301, Placebo
- Keywords
- Staphylococcus aureus, bacteremia, staphylococcal endocarditis
- Medical subject headings
- Staphylococcal Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF-301Biological
CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
PlaceboDrug
Placebo, given as a single 2 hour iv infusion
| Study group | Role | What they receive |
|---|---|---|
| CF-301 | Experimental | Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. Receives: Biological: CF-301 |
| Placebo | Placebo comparator | Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events [Safety and Tolerability]
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Measured: Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
Clinical Outcome at 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.
Measured: Day 14
CF-301 Maximum Plasma Concentration (Cmax)
CF-301 plasma concentrations at specified timepoints.
Measured: 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 Area Under the Curve (AUC 0-t)
CF-301 plasma concentrations at specified time points
Measured: 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
Secondary outcomes (7)
Clinical Outcome at 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.
Measured: Day 7
Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)
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.
Measured: EOT between 28-42 days
Clinical Outcome at Test of Cure (TOC)
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.
Measured: TOC between 56-70 days
Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration
Number and percentage of patients with clearance of bacteremia in the mITT population
Measured: Day 7
Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration
Number and percentage of patients with clearance of bacteremia in the mITT population
Measured: Day 14
Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
Number and percentage of patients with microbiological eradication in the mITT population
Measured: EOT between 28-42 days
Microbiological Eradication at Test of Cure (TOC)
Number and percentage of patients with microbiological eradication in the mITT population
Measured: TOC between 56-70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start23 May 2017
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContraFect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163446
- Sponsor's protocol ID
- CF-301-102
- Status last verified
- Sep 2021
- First submitted
- 15 May 2017
- Last updated
- 8 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fowler VG Jr, Das AF, Lipka-Diamond J, Schuch R, Pomerantz R, Jauregui-Peredo L, Bressler A, Evans D, Moran GJ, Rupp ME, Wise R, Corey GR, Zervos M, Douglas PS, Cassino C. Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis. J Clin Invest. 2020 Jul 1;130(7):3750-3760. doi: 10.1172/JCI136577.
PubMed 32271718
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03163446
- Acronym / sponsor ID
- CF-301-102
- Keywords
- Staphylococcus aureus, bacteremia, staphylococcal endocarditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- ContraFectIndustry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Posted 8 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF-301 | Experimental | Biological: CF-301Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF-301CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion | Biological | CF-301 |
| PlaceboPlacebo, given as a single 2 hour iv infusion | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Clinical Outcome at Day 7
Time frame: Day 7
Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)
Time frame: EOT between 28-42 days
Clinical Outcome at Test of Cure (TOC)
Time frame: TOC between 56-70 days
Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration
Time frame: Day 7
Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration
Time frame: Day 14
Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
Time frame: EOT between 28-42 days
Microbiological Eradication at Test of Cure (TOC)
Time frame: TOC between 56-70 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32271718Fowler VG Jr, Das AF, Lipka-Diamond J, Schuch R, Pomerantz R, Jauregui-Peredo L, Bressler A, Evans D, Moran GJ, Rupp ME, Wise R, Corey GR, Zervos M, Douglas PS, Cassino C. Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis. J Clin Invest. 2020 Jul 1;130(7):3750-3760. doi: 10.1172/JCI136577.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
78 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CF-301 in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Endocarditis, run by ContraFect at 78 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Belgium, Spain, United Kingdom, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.