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

NCT04042077 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: DELA-012018-001082-17
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Infection, Surgical Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  7-14 days after last dose

Secondary Outcomes (4)

• Hospital Infection Related Length of Stay (IRLOS)

  up to 14 days

• Hospital Length of Stay (LOS)

  up to 45 days (Late Follow Up visit)

• Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment

  up to 14 days

• Microbiological Response

  up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)

Study Arms (2)

Delafloxacin

EXPERIMENTAL

Delafloxacin IV, with the option to switch to delafloxacin oral

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.

Drug: Vancomycin; Drug: Linezolid; Drug: Piperacillin/Tazobactam; Drug: Tigecycline

Interventions

Delafloxacin DRUG

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

Delafloxacin

Vancomycin DRUG

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

Best Available Therapy

Linezolid DRUG

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

Best Available Therapy

Piperacillin/Tazobactam DRUG

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

Best Available Therapy

Tigecycline DRUG

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

Best Available Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menarini Group: lead

Study Sites (1)

Hospital Agostino Gemelli

Roma, Italy

Location

Related Publications (1)

• 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.

  PMID: 40908975 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Interventions

delafloxacin; Vancomycin; Linezolid; Piperacillin, Tazobactam Drug Combination; Tigecycline

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Corporate Director of Clinical Sciences
• Organization: Menarini Ricerche S.p.A.

acapriati@menarini-ricerche.it

0555680

Study Officials

• Stefano Margaritora

  Hospital Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the blinded observer will be unaware of the treatment assigned to patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 1, 2019
• Study Start: September 25, 2019
• Primary Completion: October 7, 2020
• Study Completion: October 28, 2020
• Last Updated: February 2, 2022
• Results First Posted: October 29, 2021

Record last verified: 2020-11

Locations

IT (1)