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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01283581
Recruitment Status : Completed
First Posted : January 26, 2011
Results First Posted : October 29, 2013
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

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 Infections) clinical trials

Condition or disease Intervention/treatment Phase
Skin and Subcutaneous Tissue Bacterial Infections Drug: Delafloxacin Drug: Linezolid Drug: Vancomycin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid
Study Start Date : January 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Delafloxacin
300 mg IV every 12 hours for 5-14 days
Drug: Delafloxacin
300mg IV every 12 hours for 5-14 days
Other Name: RX-3341

Active Comparator: Vancomycin
15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas
Drug: Vancomycin
15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days
Other Name: Vancocin

Active Comparator: Linezolid
600 mg IV every 12 hours for 5-14 days
Drug: Linezolid
600mg IV every 12 hours for 5-14 days
Other Name: Zyvox

Primary Outcome Measures :
  1. Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up and Late Follow-up. [ Time Frame: Follow-up (Day 14 ± 1) and late follow-up (Day 21-28) ]
    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 Outcome Measures :
  1. Erythema Clinical Success [ Time Frame: 48 - 72 hours ]
    The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.

  2. Steady State Pharmacokinetic Parameters in Subjects Administered Delafloxacin, Vancomycin, and Linezolid [ Time Frame: Through Day 3 (± 1 day) ]
  3. The Levels of Biochemical Markers of Inflammation [ Time Frame: on Days 1, 5, Follow-up, and late Follow-up ]
  4. Microbiological Response Rate in All Subjects and in Subjects With Infections Caused by MRSA [ Time Frame: up to Late Follow-up ]
  5. Clinical Response Rate in Subjects With Infections Caused by MRSA [ Time Frame: up to Late Follow-up ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01283581

  Show 31 Study Locations
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Study Director: Scott Hopkins, MD

Publications of Results:
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
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
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Melinta Therapeutics, Inc. Identifier: NCT01283581     History of Changes
Other Study ID Numbers: RX-3341-202
First Posted: January 26, 2011    Key Record Dates
Results First Posted: October 29, 2013
Last Update Posted: November 21, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors