Complicated skin and skin structure infections (cSSSI). MedDRA version: 9.1 Level: LLT Classification code 10040872 Term: Skin infection
Conditions
Interventions
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: oritavancin
CAS Number: 192564-14-0
Current Sponsor code: NUVOCID
Other descriptive name: oritavancin diphosphate, oritavancin bis(phosp
Sponsors
Targanta Therapeutics Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Patients must have a cSSSI, presumed or proven to be caused by gram-positive pathogen(s) that meet disease diagnostic criteria as defined in Section 9.1.1. [2] Patients, ages 18 years and older, with a BMI >17 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [1] Underlying condition which, in the opinion of the Investigator, would preclude performing protocol safety and efficacy assessments. Patients with renal insufficiency may be included if renal function is stable. FINAL PROTOCOL Approved: 03-April-2007 Confidential Targanta Therapeutics Corporation TAR-ORI-SD001 Oritavancin diphosphate Page 31 of 71 [2] Dosing with systemic antimicrobials for more than 24 hours within the last 3 days. However, a patient who has been treated for more than 24 hours may be enrolled if: • The gram-positive pathogen is resistant in vitro to the antimicrobial, OR • The patient with a proven or presumed gram-positive infection has failed to respond to antibiotic therapy and appropriate surgical management (eg, patient with presumed MRSA cellulitis who would have been changed to vancomycin, or patient with continued purulent draining from wound or abscess). Disease diagnostic criteria (see Section 9.1.1) and culture requirements (see Section 9.1.1) must still be met at the time of enrollment. [3] Any of the following entities: a. toxic shock syndrome or toxic-like syndrome (Mandell et al. 1995) b. presumed or proven infection caused by Clostridium species c. incisional wound or abscess that extends into visceral compartments d. contiguous bony involvement e. ischemic ulcers or wounds associated with arterial insufficiency or gangrene f. infections predominantly caused by aerobic or anaerobic gram-negative bacilli (i.e. decubitus ulcers or diabetic foot ulcers), unless a gram stain of an appropriate specimen indicates a predominance of gram-positive cocci g. infection of prosthetic materials that cannot be removed as part of the treatment of the current infection (see Section 10.6.2) h. infection of the scrotum, perineum or perianal region (eg, episiotomy infection, perianal cellulitis, or Fournier’s gangrene) i. infection of a full-thickness burn wound or burn wound that is approximately 20% or more of total body surface area j. malignant otitis externa k. infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset l. secondary infection of a pre-existing skin disease that may interfere with the clinical evaluations during the study. [4] Pregnancy or lactating females who are nursing and will not consent to cease nursing for at least 6 months. [5] Patients that require, or are anticipated to require, continuous therapeutic doses of unfractionated heparin either by infusion or repeated bolus where dosing is to be monitored/adjusted based on aPTT levels. Note: Patients that require, or are anticipated to require, fractionated or low molecular weight heparin or on prophylactic doses of subcutaneous unfractionated heparin may be included. [6] Poor venous access that would preclude IV drug delivery or multiple blood draws. [7] History of severe hypersensitivity reactions to glycopeptides (eg, vancomycin) (including but not limited to erythema multiform major, linear Immunoglobulin-A (IgA) dermatosis, toxic epidermal necrolysis, exfoliative dermatitis). Note: patients who have had histamine-like infusion reactions to the glycopeptide vancomycin are not excluded (see Section 10.4.1). [8] Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. [9] Patients unwilling to forego blood and/or blood product donation for at least 3 months. [10] Requirement for intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of either single dose or infrequent dosing regimens of IV oritavancin compared with daily IV dosing of 200 mg oritavancin for 3 to 7 days in the treatment of patients with cSSSI.;Secondary Objective: The secondary objective of this study is to evaluate the safety of either single dose or infrequent dosing regimens of IV oritavancin compared with daily IV dosing of 200 mg oritavancin for 3 to 7 days in the treatment of patients with cSSSI.;Primary end point(s): The primary endpoint in this study is clinical response (either cure or improvement versus failure) in clinically evaluable (CE) patients as assessed at the First Follow-Up time point. | — |
Countries
Czech Republic
Outcome results
None listed