Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
Public ClinicalTrials.gov record NCT03163446. 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 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03163446
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 121 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 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
- May 23, 2017 (Actual)
- Primary completion
- Mar 7, 2019 (Actual)
- Completion
- Mar 7, 2019 (Actual)
- Last update posted
- Oct 8, 2021
2017 – 2019
United States locations
- U.S. sites
- 31
- U.S. states
- 19
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CF-301-102 Study Site | Birmingham | Alabama | 35233 | — |
| CF-301-102 Study Site | Sacramento | California | 95817 | — |
| CF301-102 Study Site | Sylmar | California | 91342 | — |
| CF-301-102 Study Site | New Haven | Connecticut | 06511 | — |
| CF-301-102 Study Site | Newark | Delaware | 19713 | — |
| CF-301-102 Study Site | Atlanta | Georgia | 30322 | — |
| CF-301-102 Study Site | Augusta | Georgia | 30912 | — |
| CF0301-102 Study Site | Decatur | Georgia | 30033 | — |
| CF-301 Study Site | Idaho Falls | Idaho | 83404 | — |
| CF301-102 Study Site | Chicago | Illinois | 60637 | — |
| CF301-102 Study Site | Burlington | Massachusetts | 01805 | — |
| CF-301-102 Study Site | Detroit | Michigan | 48201 | — |
| CF301-102 Study Site | Royal Oak | Michigan | 48073 | — |
| CF301-102 Study Site | St Louis | Missouri | 63110 | — |
| CF301-102 Study site | Butte | Montana | 59701 | — |
| CF301-102 Study Site | Omaha | Nebraska | 68131 | — |
| CF-301-102 Study Site | Omaha | Nebraska | 68198 | — |
| CF-301-102 Study Site | Englewood | New Jersey | 07631 | — |
| CF301-102 Study Site | Paterson | New Jersey | 07102 | — |
| 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 | Valhalla | New York | 10595 | — |
| CF-301-102 Study Site | Cleveland | Ohio | 44106 | — |
| CF301-102 Study Site | Columbus | Ohio | 43210 | — |
| Cf-301-102 | Columbus | Ohio | 43215 | — |
| CF-301 Study Site | Toledo | Ohio | 43608 | — |
| CF-301-102 Study Site | Bethlehem | Pennsylvania | 18015 | — |
| Cf-301-102 | Richmond | Virginia | 23298 | — |
| CF-301-102 Study Site | Roanoke | Virginia | 24014 | — |
| CF-301-102 Study Site | Seattle | Washington | 98195 | — |
| CF-301-102 Study Site | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03163446, 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 Oct 8, 2021 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03163446 live on ClinicalTrials.gov.