A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

NCT01283581 | Completed Phase 2 Results

• 1 other identifier: RX-3341-202
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 31

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

Conditions

Skin and Subcutaneous Tissue Bacterial Infections

Outcome Measures

Primary Outcomes (1)

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

  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.

  Follow-up (Day 14 ± 1)

Secondary Outcomes (6)

• Erythema Clinical Success

  48 - 72 hours

• Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid

  Through Day 3 (± 1 day)

• 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)

Study Arms (3)

Delafloxacin

EXPERIMENTAL

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

Drug: Delafloxacin

Vancomycin

ACTIVE COMPARATOR

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

Drug: Vancomycin

Linezolid

ACTIVE COMPARATOR

600 mg IV every 12 hours for 5-14 days

Drug: Linezolid

Interventions

Delafloxacin DRUG

300mg IV every 12 hours for 5-14 days

Also known as: RX-3341

Delafloxacin

Linezolid DRUG

600mg IV every 12 hours for 5-14 days

Also known as: Zyvox

Linezolid

Vancomycin DRUG

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

Also known as: Vancocin

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subjects taking any medicinal product which inhibits monoamine oxidases A or B or within 2 weeks of Screening
• Hypertension as defined by a systolic blood pressure of ≥ 180 mmHg or a diastolic blood pressure of ≥110 mmHg with confirmed re-check within 20 minutes of initial reading
• Subjects with pheochromocytoma, thyrotoxicosis and/or subjects taking any of the following types of medications: sympathomimetic agents, vasopressive agents, dopaminergic agents, or other agents with the potential for serotonergic interactions
• Subjects with carcinoid syndrome and/or subjects taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 (serotonin receptor) receptor agonists, meperidine, or buspirone
• Known history of liver disease

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (31)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Drug Research and Analysis Corp

Montgomery, Alabama, 36106, United States

Location

Southbay Pharma Research

Buena Park, California, 90620, United States

Location

eStudySite

Chula Vista, California, 91911, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

HealthCare Partners Medical Group

Los Angeles, California, 90015, United States

Location

eStudySite

Oceanside, California, 92056, United States

Location

HealthCare Partners Medical Group

Pasadena, California, 91105, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Central Florida Internists

Kissimmee, Florida, 34741, United States

Location

Central Florida Internists Medical

Orlando, Florida, 32811, United States

Location

Central Florida Internists

Saint Cloud, Florida, 34769, United States

Location

Ronald Barbour, MD

Temple Terrace, Florida, 33617, United States

Location

Southeast Regional Research Group

Columbus, Georgia, 31904, United States

Location

Atlanta Institute for Medical Research, Inc

Decatur, Georgia, 30030, United States

Location

Southeast Regional Research Group

Savannah, Georgia, 31406, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Four Rivers Clinical Research, Inc

Paducah, Kentucky, 42003, United States

Location

Medical Development Centers, LLC

Baton Rouge, Louisiana, 70810, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

eStudySite

Las Vegas, Nevada, 89109, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

Ravi Kamepalli, MD

Lima, Ohio, 45801, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Jennifer Johnson-Caldwell, MD

Houston, Texas, 77002, United States

Location

Alan Nolasco, MD

Houston, Texas, 77005, United States

Location

Related Publications (4)

• Results of a Phase 2 Study of Delafloxacin (DLX) Compared to Vancomycin (VAN) and Linezolid (LNZ) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) J. Longcor 1 , S. Hopkins 1 , L. Lawrence 1 , S. Green 2 , P. Mehra 2 , P. Manos 2 , W. Sears 2 , W. O'Riordan 2 1 Rib - X Pharmaceuticals, Inc., New Haven, CT; 2 eStudySite, San Diego, CA 52nd ICAAC, San Francisco, CA 2012

  RESULT

• Characterization and In Vitro Activity of Delafloxacin (DLX) Against Isolates from a Phase 2 Study of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) L. Lawrence 1 , S. Hopkins 1 , D. Sahm 2 , Jennifer Deane 2 , E. Burak 1 , J. Longcor 1 1 Rib - X Pharmaceuticals, Inc., New Haven, CT; 2 Eurofins Medinet, Chantilly, VA 52nd ICAAC, San Franciso, 2012

  RESULT

• Pharmacokinetics (PK) of Delafloxacin (DLX), Vancomycin (VAN), and Linezolid (LNZ) in a Phase 2 Exploratory Study in Subjects with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) R. Hoover 1 , L. Lawrence 1 , J. Longcor 1 , J. Greenfield 2 1 Rib - X Pharmaceuticals, New Haven, CT; 2 PharmaNet/i3, The Woodlands, TX 52nd ICAAC, San Francisco, CA, 2012

  RESULT

• Kingsley J, Mehra P, Lawrence LE, Henry E, Duffy E, Cammarata SK, Pullman J. A randomized, double-blind, Phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin and skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016 Mar;71(3):821-9. doi: 10.1093/jac/dkv411. Epub 2015 Dec 17.

  PMID: 26679243 DERIVED

MeSH Terms

Interventions

delafloxacin; Linezolid; Vancomycin

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Sue Cammarata
• Organization: Melinta Therapeutics

scammarata@melinta.com

312-724-9401

Study Officials

• Scott Hopkins, MD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 16, 2019
• Results First Posted: October 29, 2013

Record last verified: 2019-09

Locations

US (31)