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

Primary Purpose

Surgical Site Infection

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Delafloxacin
Vancomycin
Linezolid
Piperacillin/Tazobactam
Tigecycline
Sponsored by
Menarini Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Site Infection focused on measuring Infection, Surgical Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Hospital Agostino Gemelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Delafloxacin

Best Available Therapy

Arm Description

Delafloxacin IV, with the option to switch to delafloxacin oral

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hospital Infection Related Length of Stay (IRLOS)
Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
Hospital Length of Stay (LOS)
Length of Stay since Screening till actual hospital discharge
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.
Microbiological Response
Documented or presumed eradication or persistence

Full Information

First Posted
July 29, 2019
Last Updated
January 25, 2022
Sponsor
Menarini Group
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1. Study Identification

Unique Protocol Identification Number
NCT04042077
Brief Title
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
Acronym
DRESS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 seriously affected the study execution as required by the protocol
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Infection, Surgical Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Only the blinded observer will be unaware of the treatment assigned to patient.
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delafloxacin
Arm Type
Experimental
Arm Description
Delafloxacin IV, with the option to switch to delafloxacin oral
Arm Title
Best Available Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Delafloxacin
Intervention Description
Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days
Intervention Type
Drug
Intervention Name(s)
Linezolid
Intervention Description
Solution for infusion or tablet, 600 mg BID, for 5 to 14 days
Intervention Type
Drug
Intervention Name(s)
Piperacillin/Tazobactam
Intervention Description
Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Intervention Description
Powder for solution for infusion 50 mg, TID, for 5 to 14 days
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Success at Test Of Cure Visit
Description
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.
Time Frame
7-14 days after last dose
Secondary Outcome Measure Information:
Title
Hospital Infection Related Length of Stay (IRLOS)
Description
Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
Time Frame
up to 14 days
Title
Hospital Length of Stay (LOS)
Description
Length of Stay since Screening till actual hospital discharge
Time Frame
up to 45 days (Late Follow Up visit)
Title
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment
Description
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.
Time Frame
up to 14 days
Title
Microbiological Response
Description
Documented or presumed eradication or persistence
Time Frame
up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Margaritora
Organizational Affiliation
Hospital Agostino Gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Agostino Gemelli
City
Roma
Country
Italy

12. IPD Sharing Statement

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

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