Trial · NCT03163446

Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

NCT03163446, Phase 2, Completed, ContraFect; results first posted 2021-10-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia. Trials, record NCT03163446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03163446

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
NCT number: NCT03163446
Status: Completed
Phases: Phase 2
Enrollment: 121 participants, actual
Lead sponsor: ContraFect
Conditions: Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Interventions: CF-301, Placebo
First posted: 2017-05-23
Last updated: 2021-10-08
Results first posted: 2021-10-08

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Adverse Events [Safety and Tolerability]	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)
Primary	Clinical Outcome at Day 14	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.
Primary	CF-301 Maximum Plasma Concentration (Cmax)	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.
Primary	CF-301 Area Under the Curve (AUC 0-t)	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	Clinical Outcome at Day 7	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.
Secondary	Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)	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.
Secondary	Clinical Outcome at Test of Cure (TOC)	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.
Secondary	Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration	Day 7	Number and percentage of patients with clearance of bacteremia in the mITT population
Secondary	Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration	Day 14	Number and percentage of patients with clearance of bacteremia in the mITT population
Secondary	Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)	EOT between 28-42 days	Number and percentage of patients with microbiological eradication in the mITT population

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Adverse Events [Safety and Tolerability]	Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180	Safety population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Clinical Outcome at Day 14	Day 14	Microbiological Intent-to-Treat (mITT) population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	CF-301 Maximum Plasma Concentration (Cmax)	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	PK Population (patients with serial PK samples)	ng/mL	MEAN
PRIMARY	CF-301 Area Under the Curve (AUC 0-t)	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	PK Population (patients with serial PK samples)	ng*hr/mL	MEAN
SECONDARY	Clinical Outcome at Day 7	Day 7	mITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)	EOT between 28-42 days	mITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Outcome at Test of Cure (TOC)	TOC between 56-70 days	mITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration	Day 7	mITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration	Day 14	mITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)	EOT between 28-42 days	mITT population	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group80

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of Adverse Events [Safety and Tolerability]	CF-301	TEAE through Day 7	48	Participants
Incidence of Adverse Events [Safety and Tolerability]	Placebo	TEAE through Day 7	30	Participants
Incidence of Adverse Events [Safety and Tolerability]	CF-301	TEAE through TOC	64	Participants
Incidence of Adverse Events [Safety and Tolerability]	Placebo	TEAE through TOC	40	Participants
Incidence of Adverse Events [Safety and Tolerability]	CF-301	TEAE through Day 180	67	Participants
Incidence of Adverse Events [Safety and Tolerability]	Placebo	TEAE through Day 180	40	Participants
Clinical Outcome at Day 14	CF-301	Responder (Improvement/Response)	50	Participants
Clinical Outcome at Day 14	Placebo	Responder (Improvement/Response)	27	Participants
Clinical Outcome at Day 14	CF-301	Non-response	18	Participants
Clinical Outcome at Day 14	Placebo	Non-response	13	Participants

1 to 10 of 80Source ClinicalTrials.gov

See all 80 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CF-301	73
Overall Study	STARTED	Placebo	48
Overall Study	COMPLETED	CF-301	45
Overall Study	COMPLETED	Placebo	31
Overall Study	NOT COMPLETED	CF-301	28
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events232

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	CF-301	5	72
other	Anemia	Blood and lymphatic system disorders	Placebo	4	47
other	Abdominal pain	Gastrointestinal disorders	CF-301	0	72
other	Abdominal pain	Gastrointestinal disorders	Placebo	4	47
other	Constipation	Gastrointestinal disorders	CF-301	9	72
other	Constipation	Gastrointestinal disorders	Placebo	5	47
other	Diarrhea	Gastrointestinal disorders	CF-301	7	72
other	Diarrhea	Gastrointestinal disorders	Placebo	3	47
other	Nausea	Gastrointestinal disorders	CF-301	6	72
other	Nausea	Gastrointestinal disorders	Placebo	3	47

1 to 10 of 232Source ClinicalTrials.gov

See all 232 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CF-301	17	73
Total, all-cause mortality	Placebo	9	48
Total, other adverse events	CF-301	62	72
Total, other adverse events	Placebo	39	47
Total, serious adverse events	CF-301	45	72
Total, serious adverse events	Placebo	28	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32271718	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MRSA - CF-301 vs MRSA - Placebo: All-cause Mortality at Day 30 in MRSA Subgroup	Trial comparisons
cBSI/R-IE - CF-301 vs cBSI/R-IE - Placebo: Clinical Responders at Day 14 in Patients With cBSI/R-IE	Trial comparisons
CF-301 vs Placebo: deaths from any cause	Trial comparisons
CF-301 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03163446

GET https://conductscience.org/api/trials/v1/NCT03163446/results?page=2

API reference For AI assistants