Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
Public ClinicalTrials.gov record NCT04160468. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE). Patients will be randomized to receive a single intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the investigators based on the protocol. 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 SoCA to treat S. aureus BSI including IE.
Study identification
- NCT ID
- NCT04160468
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 259 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 20, 2019 (Actual)
- Primary completion
- Sep 9, 2022 (Actual)
- Completion
- Sep 9, 2022 (Actual)
- Last update posted
- Nov 2, 2023
2019 – 2022
United States locations
- U.S. sites
- 55
- U.S. states
- 27
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cf 301-105 | Birmingham | Alabama | 35294 | — |
| CF-301-105 Study Site | Orange | California | 92868 | — |
| Cf 301-105 | Sacramento | California | 95817 | — |
| Cf 301-105 | San Diego | California | 92037 | — |
| CF-301-105 Investigator Site | Sylmar | California | 91342 | — |
| Cf 301-105 | Torrance | California | 90502 | — |
| CF-301-105 Study Site | Hartford | Connecticut | 06102 | — |
| Cf 301-105 | New Haven | Connecticut | 06510 | — |
| Cf 301-105 | Washington D.C. | District of Columbia | 20010 | — |
| Cf 301-105 | Washington D.C. | District of Columbia | 20037 | — |
| Cf 301-105 | Gainesville | Florida | 32608 | — |
| Cf 301-105 | Atlanta | Georgia | 30322 | — |
| Cf 301-105 | Augusta | Georgia | 30912 | — |
| Cf 301-105 | Decatur | Georgia | 30033 | — |
| CF-301-105 Study Site | Idaho Falls | Idaho | 83404 | — |
| CF-301-105 Investigator Site | Chicago | Illinois | 60637 | — |
| Cf 301-105 | Glenview | Illinois | 60026 | — |
| Cf 301-105 | Highland Park | Illinois | 60035 | — |
| Cf 301-105 | Maywood | Illinois | 60153 | — |
| Cf 301-105 | Fort Wayne | Indiana | 46804 | — |
| Cf 301-105 | Kansas City | Kansas | 66160 | — |
| Cf 301-105 | Baltimore | Maryland | 21201 | — |
| Cf 301-105 | Baltimore | Maryland | 21224 | — |
| CF 301-105 Study Site | Boston | Massachusetts | 02215 | — |
| CF-301-105 Study Site | Burlington | Massachusetts | 01805 | — |
| Cf 301-105 | Worcester | Massachusetts | 01605 | — |
| Cf 301-105 | Detroit | Michigan | 48202 | — |
| Cf 301-105 | Royal Oak | Michigan | 48073 | — |
| Cf 301-105 | Rochester | Minnesota | 55905 | — |
| CF-301-105 Study Site | Columbia | Missouri | 65212 | — |
| Cf 301-105 | St Louis | Missouri | 63110 | — |
| CF-301-105 Study Site | Butte | Montana | 59701 | — |
| Cf 301-105 | Omaha | Nebraska | 68124 | — |
| Cf 301-105 | Omaha | Nebraska | 68198 | — |
| Cf 301-105 | Neptune City | New Jersey | 07753 | — |
| Cf 301-105 | Newark | New Jersey | 07102 | — |
| Cf 301-105 | New York | New York | 10029 | — |
| Cf 301-105 | Valhalla | New York | 10595 | — |
| Cf 301-105 | Chapel Hill | North Carolina | 27599 | — |
| Cf 301-105 | Charlotte | North Carolina | 28203 | — |
| Cf 301-105 | Durham | North Carolina | 27710 | — |
| CF-301-105 Study Site | Greenville | North Carolina | 27834 | — |
| CF-301-105 Study Site | Columbus | Ohio | 43210 | — |
| Cf 301-105 | Toledo | Ohio | 43608 | — |
| Cf 301-105 | Allentown | Pennsylvania | 18103 | — |
| Cf 301-105 | Philadelphia | Pennsylvania | 19104 | — |
| Cf 301-105 | Philadelphia | Pennsylvania | 19107 | — |
| CF 301-105 Investigator Site | West Reading | Pennsylvania | 19611 | — |
| Cf 301-105 | Memphis | Tennessee | 38103 | — |
| Cf 301-105 | Memphis | Tennessee | 38105 | — |
| Cf 301-105 | Nashville | Tennessee | 37232 | — |
| Cf 301-105 | Houston | Texas | 77030 | — |
| CF-301-105 Study Site | Salt Lake City | Utah | 84108 | — |
| Cf 301-105 | Burlington | Vermont | 05401 | — |
| Cf 301-105 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04160468, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2023 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04160468 live on ClinicalTrials.gov.