18 and older, any sex, with Surgical Site Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Clinical Success at Test Of Cure VisitPrimary· 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.
Group
Value
95% CI
Delafloxacin
123
Best Available Therapy
119
Hospital Infection Related Length of Stay (IRLOS)Secondary· up to 14 days
Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
Group
Value
95% CI
Delafloxacin
130.9
± 71.87
Best Available Therapy
140.3
± 68.98
Hospital Length of Stay (LOS)Secondary· up to 45 days (Late Follow Up visit)
Length of Stay since Screening till actual hospital discharge
Group
Value
95% CI
Delafloxacin
178.8
± 95.44
Best Available Therapy
193.5
± 119.72
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's AssessmentSecondary· 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 equiv
Group
Value
95% CI
Delafloxacin
129
Best Available Therapy
129
Microbiological ResponseSecondary· 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
TOC Visit
Group
Value
95% CI
Delafloxacin
94
Best Available Therapy
81
Delafloxacin
11
Best Available Therapy
21
EOT Visit
Group
Value
95% CI
Delafloxacin
80
Best Available Therapy
64
Delafloxacin
25
Best Available Therapy
38
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06612255 — A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Ta
· Phase 1
· terminated
NCT03534622 — Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults
· Phase 1
· completed
NCT02679573 — Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia
· Phase 3
· completed
NCT02015637 — Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
· Phase 3
· terminated
Other recruiting trials for Surgical Site Infection
Currently open trials in the same condition.
NCT07501897 — Investigating the Impact of Cold Atmospheric Plasma Treatment on Wound Healing at Cannulation Sites in Patients Followin
· NA
· recruiting
NCT07311395 — Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section
· NA
· recruiting
NCT06649890 — A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
· NA
· recruiting
NCT07005635 — The Effects of Different Time Reminder On Surgical Hand Scrubing
· NA
· active not recruiting
NCT07049614 — Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients
· active not recruiting
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Trials by the same sponsor.
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· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Menarini Group
Last refreshed: 2 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04042077.