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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2020-10-28

Brief Summary

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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.

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Detailed Description

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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

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will compare delafloxacin against best available therapy selected by the investigator for the cardiothoracic/leg related or abdominal site infection

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Only the blinded observer will be unaware of the treatment assigned to patient.

Study Groups

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Delafloxacin

Delafloxacin IV, with the option to switch to delafloxacin oral

Group Type EXPERIMENTAL

Delafloxacin

Intervention Type DRUG

Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days

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.

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

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

Linezolid

Intervention Type DRUG

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

Piperacillin/Tazobactam

Intervention Type DRUG

Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days

Tigecycline

Intervention Type DRUG

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

Interventions

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Vancomycin

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

Intervention Type DRUG

Linezolid

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

Intervention Type DRUG

Piperacillin/Tazobactam

Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days

Intervention Type DRUG

Tigecycline

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

Intervention Type DRUG

Delafloxacin

Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No