MRSA Bloodstream InfectionNCT04597242
Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia
A study testing Exebacase in people with MRSA Bloodstream Infection and MRSA Bacteremia, run by ContraFect at 2 sites in United States.
Trial summary
This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA Bloodstream Infection, MRSA Bacteremia, MRSA Right-sided Endocarditis
- What is being tested?
- Exebacase
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older.
- Hospitalized with known COVID-19 infection confirmed by positive diagnostic test.
- Not eligible for the exebacase Phase 3 study (CF-301-105).
- Blood cultures positive for MRSA for ≥3 days.
- Patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential.
Who cannot join
- Known or suspected left-sided IE.
- Intubated for COVID-19.
- Presence of prosthetic valve or cardiac valve support ring, or presence of known infected orthopedic hardware, prosthetic joint, or cardiac device.
- Known or suspected brain abscess or meningitis.
- Participation in an investigational study or expanded access protocol for another antistaphylococcal antibacterial agent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CF-301-107 Study Site
Butte, Montana, 59701
Cf 301-107
Toledo, Ohio, 43608
About this study
Official title: Expanded Access Study of a Single Dose of Exebacase in Addition to Antistaphylococcal Antibiotics for the Treatment of Persistent Methicillin-Resistant Staphylococcus Aureus (MRSA) Bloodstream Infections (Including Right Sided Endocarditis) in Patients Who Are Hospitalized With Coronavirus Disease 2019 (COVID-19)
This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients will receive a single dose of exebacase. Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. Exebacase Phase 3 study sites (Study CF-301-105) may participate in this Expanded Access study (Study CF-301-107).
Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S. aureus BSI including IE.
- Being tested
- Exebacase
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExebacaseDrug
Patients will receive a single IV infusion of exebacase in addition to antistaphylococcal antibiotics prescribed by the treating physician. Patients with normal renal function or mild renal impairment will be administered a dose of 18 mg of exebacase; patients with moderate or severe renal impairment will be administered a dose of 12 mg; patients with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA Bloodstream InfectionStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- ContraFect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597242
- Sponsor's protocol ID
- CF-301-107
- Status last verified
- Sep 2021
- First submitted
- 20 Oct 2020
- Last updated
- 31 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Study of a Single Dose of Exebacase in Addition to Antistaphylococcal Antibiotics for the Treatment of Persistent Methicillin-Resistant Staphylococcus Aureus (MRSA) Bloodstream Infections (Including Right Sided Endocarditis) in Patients Who Are Hospitalized With Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04597242
- Acronym / sponsor ID
- CF-301-107
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ContraFectIndustry (pharma, biotech, devices)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients will receive a single dose of exebacase. Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. Exebacase Phase 3 study sites (Study CF-301-105) may participate in this Expanded Access study (Study CF-301-107).
Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S. aureus BSI including IE.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 years of age or older.
- Hospitalized with known COVID-19 infection confirmed by positive diagnostic test.
- Not eligible for the exebacase Phase 3 study (CF-301-105).
- Blood cultures positive for MRSA for ≥3 days.
- Patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential.
Key exclusion criteria (5 listed)
- Known or suspected left-sided IE.
- Intubated for COVID-19.
- Presence of prosthetic valve or cardiac valve support ring, or presence of known infected orthopedic hardware, prosthetic joint, or cardiac device.
- Known or suspected brain abscess or meningitis.
- Participation in an investigational study or expanded access protocol for another antistaphylococcal antibacterial agent.
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 |
|---|---|---|
| ExebacasePatients will receive a single IV infusion of exebacase in addition to antistaphylococcal antibiotics prescribed by the treating physician. Patients with normal renal function or mild renal impairment will be administered a dose of 18 mg of exebacase; patients with moderate or severe renal impairment will be administered a dose of 12 mg; patients with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exebacase in people with MRSA Bloodstream Infection and MRSA Bacteremia, run by ContraFect at 2 sites in United States.
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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 31 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.