DRESS: IV/Oral Delafloxacin In Surgical Site Infections
Research type
Research Study
Full title
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
IRAS ID
250904
Contact name
Achyut Guleri
Contact email
Sponsor organisation
MENARINI RICERCHE S.p.A.
Eudract number
2018-001082-17
Duration of Study in the UK
1 years, 0 months, 14 days
Research summary
Research Summary
This is a Phase 3 international study investigating a new drug, called delafloxacin, for the treatment of infections of the surgical wound, named surgical site infections (SSI). The aim of this study is to assess the efficacy and safety of delafloxacin, a new antibiotic which is active against multiple bacteria, with respect to the other currently used treatments in patients with infection of the wound following cardiothoracic surgery / related leg or abdominal SSI.Eligible patients will be randomly assigned to either an experimental treatment (delafloxacin) or one of two alternative treatments (Reference Treatments). The participants (and study doctors) will know which treatment group they will be in. To strengthen the reliability of the study results, this clinical trial has an observer blinded design which means that a study doctor not aware of what treatment the participant is on will be responsible for assessing whether the participant is eligible to switch from intravenous to oral therapy and whether they may be discharged from the hospital.
There are several parts to this study including: screening, to determine eligibility and the assessment period which will include treatment and follow-up. This study will include a number of examinations, tests and procedures. Participation in the study will last up to 45 days depending on treatment duration and visit schedule. Treatment will last from 5 to 14 days based on the Study Doctor’s judgment and status of the participant’s infected wound.
The study is expected to enrol 600 patients in 14 countries in Europe and it is sponsored by Menarini Ricerche S.p.A.
Summary of Results
DRESS study demonstrated that delafloxacin, given on its own, it is equally safe and effective to different available therapies widely used to treat patients with surgical site infections, mostly abdominal surgical site infection the large of recruited patients were affected of.
The efficacy of delafloxacin was coupled with the clear advantage of microbiological activity against Gram positive, negative and anaerobic bacteria, thus covering the need of an effective treatment against the wide spectrum of pathogens involved in this difficult to-treat acute bacterial skin and skin structure infection/s.
Due to the availability of intravenous and oral formulations, it allows the patients to be switched to the most convenient oral route of administration with the consequent potential advantage of shorter duration of infection related hospitalisation.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0439
Date of REC Opinion
10 Sep 2019
REC opinion
Further Information Favourable Opinion