Surgical Site InfectionPhase 3DRESSNCT04042077
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
A Phase 3 study testing Delafloxacin, Vancomycin and Linezolid in people with Surgical Site Infection, run by Menarini Group at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Delafloxacin, Vancomycin and Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2019to 28 Oct 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged more than 18 years.
- Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of superficial or deep SSI according to the CDC definition.
- The severity of infection requires an IV treatment and patient hospitalization according to the Investigator's judgment.
Who cannot join
- Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose.
- Any infection expected to require systemic antimicrobial agents other than study treatment(s).
- Medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs
- Medical history of central nervous system (CNS) disorders
- Medical history of myasthenia gravis.
- Medical history of C. difficile diarrhea.
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- Organ-space infection.
- Complicated Intra-Abdominal Infection (cIAI)
- Chronic or underlying conditions at site of infection that may complicate the assessment of clinical response or would interfere with SSI healing.
- Underlying disease leading to deep immunosuppressive status.
- End-stage renal disease, CrCl <15 mL/min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
This is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). IV to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (BAT) for either cardiothoracic/related leg or abdominal surgical site infection (SSI).
Approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or BAT. For patients who are randomised to BAT, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal SSI) as most appropriate for patient characteristics and local epidemiological pattern.
Duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per Investigator's judgment) followed by visits up to 30 days after end of treatment.
Patients will be hospitalized from Screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per Investigator's judgment.
- Conditions
- Surgical Site Infection
- Being tested
- Delafloxacin, Vancomycin, Linezolid, Piperacillin/Tazobactam, Tigecycline
- Keywords
- Infection, Surgical Infection
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelafloxacinDrug
Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
VancomycinDrug
Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days
LinezolidDrug
Solution for infusion or tablet, 600 mg BID, for 5 to 14 days
Piperacillin/TazobactamDrug
Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days
TigecyclineDrug
Powder for solution for infusion 50 mg, TID, for 5 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Delafloxacin | Experimental | Delafloxacin IV, with the option to switch to delafloxacin oral Receives: Drug: Delafloxacin |
| Best Available Therapy | Active comparator | Cardiothoracic / related leg SSI
* Vancomycin IV
* Linezolid IV, with the option to switch to linezolid oral.
In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice
Abdominal SSI
* Piperacillin/Tazobactam IV, OR
* Tigecycline IV
In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice. Receives: Drug: Vancomycin; Drug: Linezolid; Drug: Piperacillin/Tazobactam; Drug: Tigecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Success at Test Of Cure Visit
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.
Measured: 7-14 days after last dose
Secondary outcomes (4)
Hospital Infection Related Length of Stay (IRLOS)
Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
Measured: up to 14 days
Hospital Length of Stay (LOS)
Length of Stay since Screening till actual hospital discharge
Measured: up to 45 days (Late Follow Up visit)
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment
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.
Measured: up to 14 days
Microbiological Response
Documented or presumed eradication or persistence
Measured: up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start25 Sep 2019
- Primary completion7 Oct 2020
- Study completion28 Oct 2020
Why it stopped: COVID-19 seriously affected the study execution as required by the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will compare delafloxacin against best available therapy selected by the investigator for the cardiothoracic/leg related or abdominal site infection
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefano Margaritora, Principal investigator, Hospital Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042077
- Sponsor's protocol ID
- DELA-01
- Other IDs
- 2018-001082-17, 2018
- Acronym
- DRESS
- Status last verified
- Nov 2020
- First submitted
- 29 Jul 2019
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Belev N, Tein A, Mangialardi G, Nuti A, Marino Merlo G, Scartoni S, Bertolotti M, Lerro M, Margaritora S. 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. Open Forum Infect Dis. 2025 Aug 29;12(9):ofaf476. doi: 10.1093/ofid/ofaf476. eCollection 2025 Sep.
PubMed 40908975
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04042077
- Acronym / sponsor ID
- DRESS / DELA-01
- Conditions
- Surgical Site Infection
- Keywords
- Infection, Surgical Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 seriously affected the study execution as required by the protocol
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). IV to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (BAT) for either cardiothoracic/related leg or abdominal surgical site infection (SSI).
Approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or BAT. For patients who are randomised to BAT, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal SSI) as most appropriate for patient characteristics and local epidemiological pattern.
Duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per Investigator's judgment) followed by visits up to 30 days after end of treatment.
Patients will be hospitalized from Screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per Investigator's judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will compare delafloxacin against best available therapy selected by the investigator for the cardiothoracic/leg related or abdominal site infection
| Arm | Type | Receives |
|---|---|---|
| Delafloxacin | Experimental | Drug: DelafloxacinDelafloxacin IV, with the option to switch to delafloxacin oral |
| Best Available Therapy | Active comparator | Drug: Vancomycin, Drug: Linezolid, Drug: Piperacillin/Tazobactam, Drug: TigecyclineCardiothoracic / related leg SSI * Vancomycin IV * Linezolid IV, with the option to switch to linezolid oral. In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice Abdominal SSI * Piperacillin/Tazobactam IV, OR * Tigecycline IV In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged more than 18 years.
- Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of superficial or deep SSI according to the CDC definition.
- The severity of infection requires an IV treatment and patient hospitalization according to the Investigator's judgment.
Key exclusion criteria (11 listed)
- Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose.
- Any infection expected to require systemic antimicrobial agents other than study treatment(s).
- Medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs
- Medical history of central nervous system (CNS) disorders
- Medical history of myasthenia gravis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DelafloxacinPowder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days | Drug | Delafloxacin |
| VancomycinPowder for solution for infusion 15mg/kg, BID, for 5 to 14 days | Drug | Best Available Therapy |
| LinezolidSolution for infusion or tablet, 600 mg BID, for 5 to 14 days | Drug | Best Available Therapy |
| Piperacillin/TazobactamPowder for solution for infusion 4/0.5 g, TID, for 5 to 14 days | Drug | Best Available Therapy |
| TigecyclinePowder for solution for infusion 50 mg, TID, for 5 to 14 days | Drug | Best Available Therapy |
Primary outcome
Number of Participants With Clinical Success at Test Of Cure Visit
Time frame: 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.
4 secondary outcomes
Hospital Infection Related Length of Stay (IRLOS)
Time frame: up to 14 days
Hospital Length of Stay (LOS)
Time frame: up to 45 days (Late Follow Up visit)
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment
Time frame: up to 14 days
Microbiological Response
Time frame: up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40908975Belev N, Tein A, Mangialardi G, Nuti A, Marino Merlo G, Scartoni S, Bertolotti M, Lerro M, Margaritora S. 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. Open Forum Infect Dis. 2025 Aug 29;12(9):ofaf476. doi: 10.1093/ofid/ofaf476. eCollection 2025 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Margaritora principal investigator
Hospital Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Delafloxacin, Vancomycin and Linezolid in people with Surgical Site Infection, run by Menarini Group at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Success at Test Of Cure Visit (time frame: 7-14 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.