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

This study has been completed.
Information provided by (Responsible Party):
Melinta Therapeutics, Inc. Identifier:
First received: November 8, 2013
Last updated: February 22, 2016
Last verified: February 2016
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.

Condition Intervention Phase
Skin and Subcutaneous Tissue Bacterial Infections
Skin Structures and Soft Tissue Infections
Drug: delafloxacin
Drug: vancomycin
Drug: aztreonam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral 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:
  • Objective response of ≥20% reduction in lesion erythema area compared to baseline at 48 to 72 hours after initiation of treatment as determined by digital measurements of the leading edge. [ Time Frame: Baseline and at 48 to 72 hrs ] [ Designated as safety issue: No ]
    Digital photography of the infection area will be obtained at Screening, Day 1, Day 2, twice on Day 3 (12 hours apart), Day 4, Day 5, End of Treatment, Follow up, and Late Follow up using the equipment provided. The photography will be analyzed for planimetry measurements and used in the objective response assessments.

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 14±1 ] [ Designated as safety issue: No ]
  • Investigator-assessed response of signs and symptoms of infection in patients with a baseline BMI ≥30 at the Follow up Visit [ Time Frame: Up to14 ± 1 days after initiation of treatment ] [ 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 ]
  • Reduction of erythema of ≥30% at 48 to 72 hours when digital measurements are used [ Time Frame: at 48 and 72 hrs ] [ Designated as safety issue: No ]
  • Reduction in pain at End of Treatment as measured by ePRO system [ Time Frame: Up to Day 14 ] [ Designated as safety issue: No ]
  • Microbiological response of eradicated (documented or presumed) at the Follow-up Visit in all patients [ Time Frame: Up to Day 14 ] [ Designated as safety issue: No ]

Enrollment: 850
Study Start Date: May 2014
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delafloxacin
300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for up to 10 - 28 doses total
Drug: delafloxacin
Active Comparator: Vancomycin plus Aztreonam
Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for up to 10 to 28 doses
Drug: vancomycin
Drug: aztreonam

Detailed Description:
The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam.

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

Inclusion Criteria:

  • Adult (≥ 18 years of age) men or women with a diagnosis of 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 compromised immune system, 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
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Please refer to this study by its identifier: NCT01984684

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Sponsors and Collaborators
Melinta Therapeutics, Inc.
Study Director: Sue K Cammarata, MD Melinta Therapeutics, Inc.
  More Information

Responsible Party: Melinta Therapeutics, Inc. Identifier: NCT01984684     History of Changes
Other Study ID Numbers: RX-3341-303 
Study First Received: November 8, 2013
Last Updated: February 22, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Soft Tissue Infections
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors processed this record on May 24, 2016