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

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ClinicalTrials.gov Identifier: NCT04042077
Recruitment Status : Terminated (COVID-19 seriously affected the study execution as required by the protocol)
First Posted : August 1, 2019
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Menarini Group

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Delafloxacin Drug: Vancomycin Drug: Linezolid Drug: Piperacillin/Tazobactam Drug: Tigecycline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: Only the blinded observer will be unaware of the treatment assigned to patient.
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2019
Actual Primary Completion Date : October 7, 2020
Actual Study Completion Date : October 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Delafloxacin
Delafloxacin IV, with the option to switch to delafloxacin oral
Drug: Delafloxacin
Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days

Active Comparator: Best Available Therapy

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.

Drug: Vancomycin
Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days

Drug: Linezolid
Solution for infusion or tablet, 600 mg BID, for 5 to 14 days

Drug: Piperacillin/Tazobactam
Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days

Drug: Tigecycline
Powder for solution for infusion 50 mg, TID, for 5 to 14 days




Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. Hospital Infection Related Length of Stay (IRLOS) [ Time Frame: up to 14 days ]
    Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge

  2. Hospital Length of Stay (LOS) [ Time Frame: up to 45 days (Late Follow Up visit) ]
    Length of Stay since Screening till actual hospital discharge

  3. Eligibility to switch to oral formulation according to blinded observer's assessment [ Time Frame: up to 14 days ]
    Blinded assessment based on patient stabilization and ability to tolerate OS diet

  4. Microbiological response [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042077


Locations
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Italy
Hospital Agostino Gemelli
Roma, Italy
Sponsors and Collaborators
Menarini Group
Investigators
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Principal Investigator: Stefano Margaritora Hospital Agostino Gemelli
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Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT04042077    
Other Study ID Numbers: DELA-01
2018-001082-17 ( EudraCT Number )
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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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
Keywords provided by Menarini Group:
Infection, Surgical Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Surgical Wound Infection
Disease Attributes
Pathologic Processes
Wound Infection
Postoperative Complications
Vancomycin
Tazobactam
Linezolid
Piperacillin
Tigecycline
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors