A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid

Melinta Therapeutics, Inc.25 sites in 1 country256 target enrollmentJanuary 2011

ConditionsSkin and Subcutaneous Tissue Bacterial Infections

InterventionsDelafloxacin Vancomycin Linezolid

DrugsDelafloxacin Linezolid Vancomycin

Overview

Phase: Phase 2
Intervention: Delafloxacin
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Sponsor: Melinta Therapeutics, Inc.
Enrollment: 256
Locations: 25
Primary Endpoint: Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

November 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Melinta Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult (≥ 18 years of age) men or women
•Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator during participation in the study and for 30 days after the final dose of study drug
•Female partners of male subjects should also use an additional reliable method of contraception during study and for 30 days after the final dose of study drug
•Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection
•Subjects must have lymph node enlargement due to the present infection or at least one of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (\> 5.0mg/L)
•In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy

Exclusion Criteria

•A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives
•Women who are pregnant or lactating
•Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response
•Subjects with any of the following: infection involving prosthetic materials or foreign bodies, infection associated with a human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene, burns covering ≥ 10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
•Minor abscesses, unless present with one of the ABSSSI types
•Any infection expected to require other antimicrobial agents in addition to study drug
•Receipt of \> 24 hours of systemic antibiotic therapy in the 14 days before enrollment unless one of the following is documented: the subject received a single dose of a short-acting antibacterial drug 3 or more days before clinical trial enrollment for surgical prophylaxis or recently completed treatment with an antibacterial drug for an infection other than ABSSSI and the drug does not have antibacterial activity against bacterial pathogens that cause ABSSSI
•Receipt of more than 1 dose of a potentially effective antibacterial agent for treatment of the ABSSSI under study prior to enrollment
•Receipt of chronic anti-inflammatory therapy for longer than 14 days before enrollment
•Severely compromised immune systems

Arms & Interventions

Delafloxacin

300 mg IV (intravenous) every 12 hours for 5-14 days

Intervention: Delafloxacin

Vancomycin

15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas

Intervention: Vancomycin

Linezolid

600 mg IV every 12 hours for 5-14 days

Intervention: Linezolid

Outcomes

Primary Outcomes

Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up

Time Frame: Follow-up (Day 14 ± 1)

The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.

Secondary Outcomes

The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)(Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU))
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)(Follow-up (Day 14 ± 1))
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population(Follow-up (Day 14 ± 1))
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid(Through Day 3 (± 1 day))
Erythema Clinical Success(48 - 72 hours)
Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population(Follow-up (Day 14 ± 1))