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

NCT ID: NCT01283581

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Delafloxacin

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

Group Type: EXPERIMENTAL

Delafloxacin

Intervention Type: DRUG

300mg IV every 12 hours for 5-14 days

Vancomycin

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

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

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

Linezolid

600 mg IV every 12 hours for 5-14 days

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: DRUG

600mg IV every 12 hours for 5-14 days

Interventions

Delafloxacin

300mg IV every 12 hours for 5-14 days

Intervention Type: DRUG

Linezolid

600mg IV every 12 hours for 5-14 days

Intervention Type: DRUG

Vancomycin

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

Intervention Type: DRUG

Other Intervention Names

RX-3341; Zyvox; Vancocin

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
• 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
• History of severe renal impairment
• Life expectancy of < 3 months
• Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study
• Subjects previously randomized in this study or in who have received a dose of an investigational drug within 30 days of randomization
• Subjects > 140 kg in body weight

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Hopkins, MD

Role: STUDY_DIRECTOR

Locations

University of South Alabama Medical Center

Mobile, Alabama, United States

Drug Research and Analysis Corp

Montgomery, Alabama, United States

Southbay Pharma Research

Buena Park, California, United States

eStudySite

Chula Vista, California, United States

eStudySite

La Mesa, California, United States

HealthCare Partners Medical Group

Los Angeles, California, United States

eStudySite

Oceanside, California, United States

HealthCare Partners Medical Group

Pasadena, California, United States

Christiana Care Health Services

Newark, Delaware, United States

Riverside Clinical Research

Edgewater, Florida, United States

River City Clinical Research

Jacksonville, Florida, United States

Central Florida Internists

Kissimmee, Florida, United States

Central Florida Internists Medical

Orlando, Florida, United States

Central Florida Internists

Saint Cloud, Florida, United States

Ronald Barbour, MD

Temple Terrace, Florida, United States

Southeast Regional Research Group

Columbus, Georgia, United States

Atlanta Institute for Medical Research, Inc

Decatur, Georgia, United States

Southeast Regional Research Group

Savannah, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Four Rivers Clinical Research, Inc

Paducah, Kentucky, United States

Medical Development Centers, LLC

Baton Rouge, Louisiana, United States

University of Missouri Health Care

Columbia, Missouri, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

eStudySite

Las Vegas, Nevada, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Remington-Davis, Inc.

Columbus, Ohio, United States

Ravi Kamepalli, MD

Lima, Ohio, United States

Health Concepts

Rapid City, South Dakota, United States

Jennifer Johnson-Caldwell, MD

Houston, Texas, United States

Alan Nolasco, MD

Houston, Texas, United States

Countries

United States

References

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

Reference Type: 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

Reference Type: 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

Reference Type: 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.

Reference Type: DERIVED

PMID: 26679243 (View on PubMed)

Other Identifiers

RX-3341-202

Identifier Type: -

Identifier Source: org_study_id