Complicated Gram-Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus aureus. MedDRA version: 7.0 Level: LLT Classification code 10040872
Conditions
Interventions
Product Name: Telavancin
Product Code: TD-6425 Hydrochloride
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Telavancin
CAS Number: 380636-75-9
Current Sponsor code: TD-642
Sponsors
Theravance Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and Females greater than or equal to 18 years of age 2) Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA either suspected or confirmed as the major cause of the infection: -major abscess requiring surgical incision and drainage -infected burn -deep/extensive cellulitis -infected ulcer -wound infections 3) Patients must be expected to require at least 7 days of intravenous antibiotic treatment. 4) The following symptoms/signs must be present at the time of enrollment: Purulent drainage or collection, OR at least 3 of the following: -erythema -fluctuance -heat and/or localised warmth -pain and/or tenderness to palpation -swelling and/or induration -fever (as defined as >38oC/100.4oF orally, rectally or tympanically) -WBC count > 10,000/mm3 ->15% immature neutrophils (bands) irrespective of WBC count 5) Accessible site for culture 6) Informed consent can be obtained for participation in this study as defined by the local Institutional Review Board or Ethics Committee Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) a. Received more than 24 hrs of potentially effective systemic (IV/IM or PO) antibiotic therapy prior to randomisation, unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days), and/or b. Requires a non-study systemic (IV/IM or PO) antibacterial regimen to which the target pathogen is susceptible. 2) Requirement for concomitant administration of agents containing a cyclodextrin solubilizer such as intravenous Sporanox® (itraconazole) or Vfend® (voriconazole). 3) Patients with baseline QTc >500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy. 4) Uncomplicated skin and superficial skin structure infection (e.g. simple abscess, impetiginous lesion, furuncle or superficial cellulitis). 5) Self-limited infection (e.g. isolated folliculitis or other infection that has a high surgical incision cure rate, or furunculosis or carbunculosis that is not associated with a cellulitis at least 2cm in radius). 6) Superinfected eczema, hidradenitis suppurativa or other chronic medical conditions (e.g. atopic dermatitis) where inflammation may be prominent for an extended period even after successful bacterial eradication. 7) Concurrent infections of unremovable prosthetic materials (e.g. permanent cardiac pacemaker battery packs, or joint replacement prosthesis). 8) Concurrent presence of osteomyelitis, endocarditis or other deep site tissue infection other than skin and skin structure infection. 9) Infections due to Gram-positive organism known to be resistant to vancomycin (e.g. vancomycin-resistant enterococcus) or Gram-negative organisms known to be resistant to aztreonam. 10) Burns involving >20% of body surface area or third degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotising fasciitis, gas gangrene, or mediastinitis. 11) Severely neutropenic (absolute neutrophil count < 500 cells/mm3) or anticipated to develop severe neutropenia during the study treatment period due to prior or planned chemotherapy or have HIV with known CD4 count < 100 cells/mm3 during the last 6 months. 12) Known hypersensitivity to or intolerance of study medications or their formulation excipients. 13) a. Female patients of childbearing potential if they are pregnant, nursing or unable to use a highly effective method of birth control during the study and for at least one month following the last dose of study medication. A negative serum pregnancy test must be documented prior to treatment. A highly effective method of birth control is defined as one that results in a low failure rate (i.e. < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUD's, sexual abstinence, or a vasectomised partner. b. Male patients must agree to use medically acceptable birth control for at least three months following last dose of study medication. A vasectomy or a condom used with a spermicide is a medically acceptable birth control method for males. 14) Prior enrollment in a clinical trial of telavancin. 15) Treatment with another investigational medication/device within 30 days of study entry. 16) Patients in shock or who are unlikely to survive through the treatment and evaluation period. 17) Patients unable to comply with the study procedures. 18) Any other condition which, in the opinion of an investigat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of Telavancin to Vancomycin in the treatment of adults with Complicated Gram-Positive Skin and Skin Structure Infections with an emphasis on patients with infections due to MRSA.;Secondary Objective: To pool the data from this study with those from a second study of identical design (protocol 0017) and to assess the superiority of Telavancin to Vancomycin in patients with MRSA.;Primary end point(s): Primary efficacy endpoint is the clinical response determined by the investigator at the Test-of-Cure assessment. For purpose of analysis, assessments of "not cured" at End-of-Therapy will be carried forward to Test-of-Cure. Secondary Efficacy endpoints are: -By-pathogen microbiologic response at Test-of-Cure for MRSA, determined from cultures of the primary infection site. Response will be categorised as "eradicated" or "not eradicated". -By-patient microbiologic response at Test-of-Cure, categorised as "eradicated" or "not eradicated". -Overall therapeutic response at Test-of-Cure, scored as "overall cure" or "failure" according to the patient's combination of clinical response and by-patient microbiologic response. Tertiary Efficacy endpoints are: -Clinical response at End-of-Therapy -By-pathogen microbiologic response at End-of-Therapy, and Test-of-Cure for each Gram-positive baseline pathogen (other than MRSA at Test-of-Cure) -By-patient microbiologic response at End-of-Therapy -Duration of treatment with study medication -Time to resolution of fever, defined as the first day of the earliest 2-day period during which all temperatures were less than or equal to 38oC -Total signs and symptoms score on days 2-7, at End-of-Therapy, and at Test-of-Cure. The assessments of erythema, flactuance, localised warmth, pain/tenderness and edema/induration will each be scored as 0 (absent) or 1 (present). Wound drainage will be scored as 0 (absent), 1 (non-purulent) or 2 (purulent). Total score will be calculated as the sum o | — |
Countries
Italy, Lithuania, United Kingdom
Outcome results
None listed