Evidence map›Paper›PMID 40908975›Full record

Trial reportOpen forum infectious diseases2025

A Randomized, Observer-Blinded, Active-Controlled, Phase IIIb Study to Compare IV/Oral Delafloxacin Fixed-Dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections: The DRESS Study.

Nikolay Belev, Andres Tein, Giuseppe Mangialardi, Alessandra Nuti, Giovanni Marino Merlo, Simona Scartoni, Monica Bertolotti, Margherita Lerro, Stefano Margaritora

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Open forum infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04042077 (A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04042077 phase3terminatednot on this map

A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections

TypeinterventionalSponsorMenarini GroupRan2019 to 2020Enrolled268ConditionsSurgical Site InfectionArmsDelafloxacin, Vancomycin, Linezolid, Piperacillin/Tazobactam, Tigecycline
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Delafloxacin: what does a new fluoroquinolone offer?Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Nikolay BelevUniversity Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv," Plovdiv, Bulgaria.
Andres TeinDepartment of Surgery, Tartu University Hospital, Tartu, Estonia.
Giuseppe MangialardiGlobal Clinical Sciences, Menarini Ricerche SpA, Florence, Italy.
Alessandra NutiGlobal Clinical Sciences, Menarini Ricerche SpA, Florence, Italy.
Giovanni Marino MerloGlobal Clinical Sciences, Menarini Ricerche SpA, Florence, Italy.
Simona ScartoniGlobal Clinical Sciences, Menarini Ricerche SpA, Florence, Italy.
Monica BertolottiGlobal Clinical Sciences, Menarini Ricerche SpA, Florence, Italy.
Margherita LerroGlobal Clinical Sciences, Menarini Ricerche SpA, Florence, Italy.
Stefano MargaritoraFaculty of Medicine and Surgery, Catholic University of Sacred Heart, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Surgical site infections (SSIs) are the most common skin and skin structure infections and are mostly polymicrobial, requiring hospitalization and broad-spectrum antibiotics. This clinical trial evaluated the noninferiority of delafloxacin vs best available therapy (BAT) for the treatment of superficial or deep incisional SSI following a cardiothoracic/related leg or abdominal surgical procedure. Methods: In this randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study, patients with SSI were randomized 1:1 to receive delafloxacin 300 mg intravenous (IV)/450 mg oral (OS) or BAT IV/OS (vancomycin or linezolid for cardiothoracic SSI, piperacillin/tazobactam or tigecycline for abdominal SSI). The primary end point was clinical success, defined as the clinical response (cure or improved) at test of cure (TOC), performed 7-14 days after end of treatment (EOT) visit. Secondary end points were clinical success at EOT, sustained clinical response at last follow-up (LFU), microbiological response, and safety. Results: Thi study enrolled 266 patients (delafloxacin = 134; BAT = 132) with comparable baseline characteristics between the 2 treatment arms. Delafloxacin clinical success was noninferior vs BAT at TOC visit (91.8% vs 90.2%, respectively). Similar efficacy was confirmed at LFU (91.8% delafloxacin; 87.9% BAT). Comparable microbiological response was obtained with delafloxacin (89.5%) and BAT (79.4%). Delafloxacin and BAT demonstrated comparable treatment adverse event rates (23.9% and 19.7%, respectively), mostly mild-to-moderate gastrointestinal reactions. Conclusions: This study provided new data on delafloxacin in SSIs, covering the need for effective empiric treatment against the wide spectrum of pathogens involved in these infections. Clinical Trials registration: NCT04042077; 2018-001082-17 (EudraCT).

Indexed as

acute bacterial skin and skin structure infections (ABSSSIs)clinical successdelafloxacinsafetysurgical site infections (SSIs)

Identifiers

PMID40908975
PMCPMC12406695

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.