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

NCT04042077 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2022-02-02

Study results available
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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.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Delafloxacin

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

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

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Stefano Margaritora · Hospital Agostino Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2020-10-07
Completion
2020-10-28
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042077 on ClinicalTrials.gov