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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283581
First Posted: January 26, 2011
Last Update Posted: November 21, 2013
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.
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
January 24, 2011
January 26, 2011
August 23, 2013
October 29, 2013
November 21, 2013
January 2011
November 2011   (Final data collection date for primary outcome measure)
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.
  • cessation of spread of redness, edema, or induration of the lesion [ Time Frame: up to 5 Days after enrollment ]
    in the ITT population
  • resolution of fever (absence) [ Time Frame: up to 5 Days after enrollment ]
    in the ITT population
Complete list of historical versions of study NCT01283581 on ClinicalTrials.gov Archive Site
  • 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%.
  • Steady State Pharmacokinetic Parameters in Subjects Administered Delafloxacin, Vancomycin, and Linezolid [ Time Frame: Through Day 3 (± 1 day) ]
  • The Levels of Biochemical Markers of Inflammation [ Time Frame: on Days 1, 5, Follow-up, and late Follow-up ]
  • Microbiological Response Rate in All Subjects and in Subjects With Infections Caused by MRSA [ Time Frame: up to Late Follow-up ]
  • Clinical Response Rate in Subjects With Infections Caused by MRSA [ Time Frame: up to Late Follow-up ]
  • clinical resolution of infection [ Time Frame: up to late follow-up visit (day 21-28) ]
  • clinical response in patients with MRSA infections [ Time Frame: up to late follow-up visit (day 21-28) ]
  • microbiological response rate [ Time Frame: up to late follow-up visit (day 21-28) ]
Not Provided
Not Provided
 
A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Skin and Subcutaneous Tissue Bacterial Infections
  • Drug: Delafloxacin
    300mg IV every 12 hours for 5-14 days
    Other Name: RX-3341
  • Drug: Linezolid
    600mg IV every 12 hours for 5-14 days
    Other Name: Zyvox
  • Drug: Vancomycin
    15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days
    Other Name: Vancocin
  • Experimental: Delafloxacin
    300 mg IV every 12 hours for 5-14 days
    Intervention: Drug: Delafloxacin
  • Active Comparator: Vancomycin
    15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas
    Intervention: Drug: Vancomycin
  • Active Comparator: Linezolid
    600 mg IV every 12 hours for 5-14 days
    Intervention: Drug: Linezolid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01283581
RX-3341-202
No
Not Provided
Not Provided
Melinta Therapeutics, Inc.
Melinta Therapeutics, Inc.
Not Provided
Study Director: Scott Hopkins, MD
Melinta Therapeutics, Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP