Trial · NCT04160468

Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

NCT04160468, Phase 3, Terminated, ContraFect; results first posted 2023-10-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase. Trials, record NCT04160468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04160468

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Trial

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

Title: Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
NCT number: NCT04160468
Status: Terminated
Phases: Phase 3
Enrollment: 259 participants, actual
Lead sponsor: ContraFect
Conditions: Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Interventions: Exebacase, Placebo
First posted: 2019-11-13
Last updated: 2023-11-02
Results first posted: 2023-10-18

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	Day 14	Clinical outcome of responder was defined as survival with resolution or 2-grade improvement of attributable signs and symptoms and negative blood cultures by Day 14, and without new signs or symptoms, new metastatic foci or septic emboli, or change in antibiotics due to lack of response.
Primary	Treatment-emergent Adverse Events (TEAEs) Through Day 60	Through Day 60	Number and percentage of patients with treatment-emergent adverse events (TEAEs)

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	Day 14	MRSA population in the mITT analysis set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Treatment-emergent Adverse Events (TEAEs) Through Day 60	Through Day 60	Safety analysis set	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Units
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	Exebacase + SoCA	Responder	32	Participants
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	SoCA Alone	Responder	20	Participants
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	Exebacase + SoCA	Failure	30	Participants
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	SoCA Alone	Failure	13	Participants
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	Exebacase + SoCA	Indeterminate	2	Participants
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	SoCA Alone	Indeterminate	0	Participants
Treatment-emergent Adverse Events (TEAEs) Through Day 60	Exebacase + SoCA		142	Participants
Treatment-emergent Adverse Events (TEAEs) Through Day 60	SoCA Alone		72	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Exebacase + SoCA	173
Overall Study	STARTED	SoCA Alone	86
Overall Study	COMPLETED	Exebacase + SoCA	142
Overall Study	COMPLETED	SoCA Alone	81
Overall Study	NOT COMPLETED	Exebacase + SoCA	31
Overall Study	NOT COMPLETED	SoCA Alone	5

Source ClinicalTrials.gov

Adverse events236

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	Pneumonia	Infections and infestations	Exebacase + SoCA	5	165
other	Pneumonia	Infections and infestations	SoCA Alone	6	85
other	Urinary tract infection	Infections and infestations	Exebacase + SoCA	3	165
other	Urinary tract infection	Infections and infestations	SoCA Alone	5	85
other	Constipation	Gastrointestinal disorders	Exebacase + SoCA	13	165
other	Constipation	Gastrointestinal disorders	SoCA Alone	11	85
other	Diarrhea	Gastrointestinal disorders	Exebacase + SoCA	12	165
other	Diarrhea	Gastrointestinal disorders	SoCA Alone	3	85
other	Pleural effusion	Respiratory, thoracic and mediastinal disorders	Exebacase + SoCA	10	165
other	Pleural effusion	Respiratory, thoracic and mediastinal disorders	SoCA Alone	9	85

1 to 10 of 236Source ClinicalTrials.gov

See all 236 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Exebacase + SoCA	27	165
Total, all-cause mortality	SoCA Alone	14	85
Total, other adverse events	Exebacase + SoCA	72	165
Total, other adverse events	SoCA Alone	41	85
Total, serious adverse events	Exebacase + SoCA	71	165
Total, serious adverse events	SoCA Alone	34	85

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33910968	DERIVED	PubMed
38297916	DERIVED	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 comparisons3

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

Comparison	Source
Exebacase + SoCA vs SoCA Alone: Treatment-emergent Adverse Events (TEAEs) Through Day 60	Trial comparisons
Exebacase + SoCA vs SoCA Alone: deaths from any cause	Trial comparisons
Exebacase + SoCA vs SoCA Alone: 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/NCT04160468

GET https://conductscience.org/api/trials/v1/NCT04160468/events?page=2

API reference For AI assistants