Trial · NCT04042077

Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

NCT04042077, Phase 3, Terminated, Menarini Group; results first posted 2021-10-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections. Trials, record NCT04042077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04042077

On this page

Trial

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

Title: Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
NCT number: NCT04042077
Status: Terminated
Phases: Phase 3
Enrollment: 268 participants, actual
Lead sponsor: Menarini Group
Conditions: Surgical Site Infection
Interventions: Delafloxacin, Vancomycin, Linezolid, Piperacillin/Tazobactam, Tigecycline
First posted: 2019-08-01
Last updated: 2022-02-02
Other registries' IDs: eudract:2018-001082-17
Results first posted: 2021-10-29

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinical Success at Test Of Cure Visit	7-14 days after last dose	Clinical Success defined as the clinical response of "Cure" or "improved". Below the definitions: * Cure: The complete resolution of all baseline signs and symptoms of SSI * Improved: two or more signs and/or symptoms (but not all) were considered resolved thus the patient had improved to an extent that no additional antibiotic treatment was necessary.
Secondary	Hospital Infection Related Length of Stay (IRLOS)	up to 14 days	Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
Secondary	Hospital Length of Stay (LOS)	up to 45 days (Late Follow Up visit)	Length of Stay since Screening till actual hospital discharge
Secondary	Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment	up to 14 days	Blinded assessment based on patient stabilization and ability to tolerate OS diet. In particular, the following details had to be met: Systolic blood pressure normal/not clinically significant abnormal No infection related tachycardia Afebrile status; body temperature \<38°C for at least 24 hours\* WBC count normalized/not clinically significant abnormal Patient able to tolerate PO diet/to take PO treatment and no GI absorption problem The measure counts only the participants eligible to switch, without taking into account the actually switched. Indeed, only linezolid in the BAT has an equivalent oral formulation suitable for the switch.
Secondary	Microbiological Response	up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)	Documented or presumed eradication or persistence

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Clinical Success at Test Of Cure Visit	7-14 days after last dose	ITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hospital Infection Related Length of Stay (IRLOS)	up to 14 days	CE population	hours	MEAN
SECONDARY	Hospital Length of Stay (LOS)	up to 45 days (Late Follow Up visit)	ITT population	hours	MEAN
SECONDARY	Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment	up to 14 days	ITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Microbiological Response	up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)	MITT population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Clinical Success at Test Of Cure Visit	Delafloxacin		123		Participants
Number of Participants With Clinical Success at Test Of Cure Visit	Best Available Therapy		119		Participants
Hospital Infection Related Length of Stay (IRLOS)	Delafloxacin		130.9	Standard Deviation 71.87	hours
Hospital Infection Related Length of Stay (IRLOS)	Best Available Therapy		140.3	Standard Deviation 68.98	hours
Hospital Length of Stay (LOS)	Delafloxacin		178.8	Standard Deviation 95.44	hours
Hospital Length of Stay (LOS)	Best Available Therapy		193.5	Standard Deviation 119.72	hours
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment	Delafloxacin		129		Participants
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment	Best Available Therapy		129		Participants
Microbiological Response	Delafloxacin	TOC Visit / Eradicated	94		Participants
Microbiological Response	Best Available Therapy	TOC Visit / Eradicated	81		Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow14

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Delafloxacin	134
Overall Study	STARTED	Best Available Therapy	132
Overall Study	Vancomycin IV	Delafloxacin	0
Overall Study	Vancomycin IV	Best Available Therapy	2
Overall Study	Linezolid IV, With the Option to Switch to Linezolid Oral	Delafloxacin	0
Overall Study	Linezolid IV, With the Option to Switch to Linezolid Oral	Best Available Therapy	8
Overall Study	Piperacillin/Tazobactam IV	Delafloxacin	0
Overall Study	Piperacillin/Tazobactam IV	Best Available Therapy	68
Overall Study	Tigecycline IV	Delafloxacin	0
Overall Study	Tigecycline IV	Best Available Therapy	54

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

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	diarrhoea	Gastrointestinal disorders	Delafloxacin	3	134	3
other	diarrhoea	Gastrointestinal disorders	Best Available Therapy	3	132	3
other	diarrhoea	Gastrointestinal disorders	Linezolid	0	8	0
other	diarrhoea	Gastrointestinal disorders	Vancomycin	0	2	0
other	diarrhoea	Gastrointestinal disorders	Piperacillin/Tazobactam	1	68	1
other	diarrhoea	Gastrointestinal disorders	Tigecycline	2	54	2
other	nausea	Gastrointestinal disorders	Delafloxacin	2	134	2
other	nausea	Gastrointestinal disorders	Best Available Therapy	0	132	0
other	nausea	Gastrointestinal disorders	Linezolid	0	8	0
other	nausea	Gastrointestinal disorders	Vancomycin	0	2	0

1 to 10 of 288Source ClinicalTrials.gov

See all 288 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Delafloxacin	4	134
Total, all-cause mortality	Best Available Therapy	1	132
Total, all-cause mortality	Linezolid	0	8
Total, all-cause mortality	Vancomycin	0	2
Total, all-cause mortality	Piperacillin/Tazobactam	0	68
Total, all-cause mortality	Tigecycline	1	54
Total, other adverse events	Delafloxacin	22	134
Total, other adverse events	Best Available Therapy	26	132
Total, other adverse events	Linezolid	2	8
Total, other adverse events	Vancomycin	0	2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40908975	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
Delafloxacin vs Best Available Therapy: Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment	Trial comparisons
Delafloxacin vs Best Available Therapy: Number of Participants With Clinical Success at Test Of Cure Visit	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/NCT04042077

GET https://conductscience.org/api/trials/v1/NCT04042077/events?page=2

API reference For AI assistants