Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01811732
First received: March 8, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with complicated bacterial and soft tissue infections.


Condition Intervention Phase
Acute Bacterial Skin and Skin Structure Infections
Drug: Delafloxacin
Drug: Vancomycin
Drug: Aztreonam
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections

Resource links provided by NLM:


Further study details as provided by Melinta Therapeutics, Inc.:

Primary Outcome Measures:
  • area measurements of lesion erythema at primary infection site [ Time Frame: baseline and at 48 to 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator-assessed response of signs and symptoms of infection at the Follow-up Visit (EMA primary endpoint) [ Time Frame: up to day 28 ] [ Designated as safety issue: No ]
    lesion size, warmth, redness and discharge; White Blood Cell (WBC) count, body temperature

  • Investigator-assessed response of signs and symptoms of infection in patients with a baseline body mass index ≥30 at the Follow-up Visit [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
  • Investigator-assessed response of signs and symptoms of infection at the Late Follow-up Visit [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
  • Objective response using reduction of erythema of ≥30% at 48 to 72 hours when digital measurements are used [ Time Frame: Baseline and at 48 to 72 hours ] [ Designated as safety issue: No ]
    Scale

  • Reduction of erythema of ≥80% at the Follow-up Visit when digital measurements are used [ Time Frame: Up to day 28 ] [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: April 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delafloxacin plus placebo
300mg iv every 12 hours for up to 10 to 28 doses
Drug: Delafloxacin
Delafloxacin
Other Name: RX-3341-83
Drug: Placebo
Placebo
Other Names:
  • 5% Dextrose
  • D5W
Active Comparator: Vancomycin plus Aztreonam + placebo
Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for up to 10 to 28 doses
Drug: Vancomycin
Vancomycin
Drug: Aztreonam
Aztreonam
Drug: Placebo
Placebo
Other Names:
  • 5% Dextrose
  • D5W

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (≥ 18 years of age) men or women with a diagnosis of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with at least two signs of systemic infection
  • In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy, and the subject must be able and willing to comply with protocol requirements

Exclusion Criteria:

  • A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator
  • Women who are pregnant or lactating
  • Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures
  • Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of <3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811732

  Show 50 Study Locations
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Investigators
Study Director: Sue K. Cammarata, MD, CMO Melinta Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01811732     History of Changes
Other Study ID Numbers: RX-3341-302, 2012-001767-71
Study First Received: March 8, 2013
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Melinta Therapeutics, Inc.:
Bacterial skin infection
skin infection
infection
skin
delafloxacin
vancomycin
aztreonam
MRSA bacteria
bacterial infection
Anti-Infective Agents
Anti-Bacterial Agents

Additional relevant MeSH terms:
Infection
Communicable Diseases
Fluoroquinolones
Aztreonam
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014