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.
Melinta Therapeutics, Inc.
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
First received: November 8, 2013
Last updated: November 14, 2013
Last verified: November 2013
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.
Acute Bacterial Skin Infection
Skin Structure Infection
|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:
U.S. FDA Resources
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 ]
|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)|
300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for up to 10 - 28 doses total
Active Comparator: Vancomycin plus Aztreonam
Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for up to 10 to 28 doses
Contacts and Locations
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