Trial · NCT03894046

Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex

NCT03894046, Phase 3, Completed, Entasis Therapeutics; results first posted 2023-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex. Trials, record NCT03894046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03894046

On this page

Trial

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

Title: Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
NCT number: NCT03894046
Status: Completed
Phases: Phase 3
Enrollment: 207 participants, actual
Lead sponsor: Entasis Therapeutics
Conditions: Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia, Colistin Resistant ABC
Interventions: Sulbactam, Durlobactam, Colistin, Imipenem/Cilastatin 500 mg/500 mg
First posted: 2019-03-28
Last updated: 2023-02-01
Results first posted: 2023-02-01

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population	28 Days	The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.
Primary	Proportion of Patients With Nephrotoxicity	28 days	The primary safety endpoint for the study is nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A.

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	Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population	28 Days	CRABC m-MITT (Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex Microbiologically Modified Intent-to-Treat Population).~The CRABC m-MITT Population included patients who met m-MITT criteria and had a baseline ABC organism that was confirmed to be carbapenem-resistant (MIC of imipenem/meropenem ≥8 ug/mL) by the central laboratory or by the local laboratory.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Proportion of Patients With Nephrotoxicity	28 days	MITT (Modified Intent To Treat population containing all patients who received any amount of study drug).~Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population	Part A - Group 1	12	Participants
Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population	Part A - Group 2	20	Participants
Proportion of Patients With Nephrotoxicity	Part A - Group 1	12	Participants
Proportion of Patients With Nephrotoxicity	Part A - Group 2	32	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Part A - Group 1	92
Overall Study	STARTED	Part A - Group 2	89
Overall Study	STARTED	Part B - Group 3	26
Overall Study	COMPLETED	Part A - Group 1	69
Overall Study	COMPLETED	Part A - Group 2	61
Overall Study	COMPLETED	Part B - Group 3	20
Overall Study	NOT COMPLETED	Part A - Group 1	23
Overall Study	NOT COMPLETED	Part A - Group 2	28
Overall Study	NOT COMPLETED	Part B - Group 3	6

Source ClinicalTrials.gov

Adverse events288

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	Events
other	Hypotension	Vascular disorders	Part A - Group 1	5	91	5
other	Hypotension	Vascular disorders	Part A - Group 2	5	86	5
other	Hypotension	Vascular disorders	Part B - Group 3	1	28	1
other	Pyrexia	General disorders	Part A - Group 1	9	91	14
other	Pyrexia	General disorders	Part A - Group 2	8	86	11
other	Pyrexia	General disorders	Part B - Group 3	1	28	1
other	Blood creatinine increased	Investigations	Part A - Group 1	2	91	6
other	Blood creatinine increased	Investigations	Part A - Group 2	7	86	10
other	Blood creatinine increased	Investigations	Part B - Group 3	3	28	3
other	Blood alkaline phosphatase increased	Investigations	Part A - Group 1	0	91	0

1 to 10 of 288Source ClinicalTrials.gov

See all 288 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part A - Group 1	25	91
Total, all-cause mortality	Part A - Group 2	31	86
Total, all-cause mortality	Part B - Group 3	4	28
Total, other adverse events	Part A - Group 1	48	91
Total, other adverse events	Part A - Group 2	53	86
Total, other adverse events	Part B - Group 3	14	28
Total, serious adverse events	Part A - Group 1	36	91
Total, serious adverse events	Part A - Group 2	42	86
Total, serious adverse events	Part B - Group 3	9	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37182534	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 comparisons2

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

Comparison	Source
Part A - Group 1 vs Part A - Group 2: Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population	Trial comparisons
Part A - Group 1 vs Part A - Group 2: Proportion of Patients With Nephrotoxicity	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/NCT03894046

GET https://conductscience.org/api/trials/v1/NCT03894046/events?page=2

API reference For AI assistants