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

This study is not yet open for participant recruitment.
Verified November 2013 by Melinta Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01984684
First received: November 8, 2013
Last updated: November 14, 2013
Last verified: November 2013
  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 Infection
Skin Structure Infection
Drug: delafloxacin
Drug: vancomycin
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 and Safety of IV and 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 ]

Estimated Enrollment: 660
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 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
1
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
2

  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 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01984684     History of Changes
Other Study ID Numbers: RX-3341-303
Study First Received: November 8, 2013
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 23, 2014