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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: March 13, 2017
Last verified: March 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]
    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 ]
  • 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 ]
  • Investigator-assessed response of signs and symptoms of infection at the Late Follow-up Visit [ Time Frame: Up to Day 28 ]
  • Reduction of erythema of ≥30% at 48 to 72 hours when digital measurements are used [ Time Frame: at 48 and 72 hrs ]
  • Reduction in pain at End of Treatment as measured by ePRO system [ Time Frame: Up to Day 14 ]
  • Microbiological response of eradicated (documented or presumed) at the Follow-up Visit in all patients [ Time Frame: Up to Day 14 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 identifier: NCT01984684

  Show 94 Study Locations
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: March 13, 2017

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

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Soft Tissue Infections
Anti-Bacterial Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017