An open label, multi-center, randomized, comparative Phase IIIb study to compare efficacy and safety of intravenous (i.v.) daptomycin with that of Semi-synthetic Penicillins (SSPs) or vancomycin in the treatment of elderly patients (aged ≥ 65 years) with complicated Skin and Soft Tissue Infections (cSSTIs) - ND

ovartis Pharma AG0 个研究点目标入组 146 人开始时间: 2009年12月23日最近更新: 2012年4月24日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: ovartis Pharma AG
入组人数: 146

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Written informed consent to participate in the study. In the event that the patient is unable to give consent, the patient`s legally authorized representative may do so by means approved by the investigator s EC. 2. Patients with age of 65 years or older. 3. Infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours. 4. Patients who have a diagnosis of Gram-positive complicated skin and soft tissue infections (cSSTIs) with or without bacteremia, e.g.: wound infections due to: o traumatic injury (e.g., crush, puncture, laceration, gunshot, etc.), o surgical incision, o foreign body (e.g., septic phlebitis associated with intravenous catheter sites). Infected foreign bodies (e.g., implanted pacemakers) are to be removed within 24 hours following study enrolment. major abscesses which are defined as meeting all the following criteria: o involve the subcutaneous or deeper tissues o require surgical incision and drainage, o require antibiotic therapy in addition to drainage. severe carbunculosis, infected ulcers (except patients with multiple infected ulcers, see exclusion criteria) associated with: diabetes, vascular insufficiency, pressure (i.e., decubitus ulcers), presence of a complicating factor, including: o a pre-existing skin lesion or underlying condition that adversely affected the delivery of drug to the affected area, the immunologic response, or tissue healing, o requirement for significant surgical intervention, o suspected or confirmed involvement of deep soft tissues, fascia, or muscle, o chronic systemic steroids (> 20 mg prednisone daily or equivalent), o diabetes mellitus requiring treatment with oral hypoglycemic agents or insulin. 5. Presence of at least 3 of the following signs and symptoms of skin infection: temperature > 38.0C rectal or > 37.5C oral/tympanic, elevated WBC >12x 103/μL or with > 10 % bands (immature neutrophils), drainage and/ or discharge from the infection site, erythema (extending at least 1 cm beyond wound edge), fluctuance, heat and/ or localized warmth, pain and/ or tenderness to palpation, edema and/ or induration.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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

排除标准

•Non-complicated SSTI: 1.Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (e.g., amputation). 2.Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo). 3.Cellulitis, including erysipelas, not associated with complicating factors. However, patients with cellulitis associated with more serious infection (e.g., surgical wound, diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited to 30%). Infections for which outcome is difficult to assess: 4.Perirectal abscess 5.Hidradenitis suppurativa 6.Gangrene 7.Infected human or animal bites 8.Multiple infected ulcers at distant sites 9.Infected burns (only 3rd degree burn wound or wound area of more than 10 cm diameter) 10.Conditions requiring emergency surgery including necrotizing fasciitis. Medical conditions: 11.History of significant allergy or intolerance to vancomycin or daptomycin. Hypersensitivity to the selected SSPs is not an exclusion criterion. 12.Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluation in this protocol such as primary muscle disorders, pneumonia, endocarditis, osteomyelitis, septic arthritis, meningitis, spinal epidural abscess, intraabdominal infection (peritonitis, etc.) and intravascular devicerelated bacteremia. 13.Infections associated with a permanent prosthetic device that will not be removed within 24 hours after enrolment. 14.Shock or hypotension (supine systolic blood pressure < 80 mm Hg) refractory to fluid or short course pressor challenge (> 4 hours). 15.Neutrophil count < 1000/μL. 16.Known or suspected HIV infection with a CD4+ T-cell count < 500/μL (HIV testing is not required). 17.Severe hepatic disease (Child-Pugh Class C) or ALT and/or AST > 5 times ULN and/ or total bilirubin > 2 times ULN at screening. 18.Calculated creatinine clearance by the Cockcroft-Gault equation using actual body weight < 30 mL/min or any type of dialysis. 19.Life expectancy less than six months. 20.Treatment with any investigational agent or device within 30 days of study drug administration. 21.Patients unwilling or unable to adhere to study-designated procedures and restrictions. 22.Patients admitted to the hospital for drug abuse or other conditions associated with rhabdomyolysis. Exclusion criteria related to microbiology 23.Patients with an infection due to an organism known to be resistant to daptomycin or vancomycin at study entry. 24.cSSTIs suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on the epidemiology or on direct examination of a Gram- stained specimen. Exclusion criteria related to medications 25.Need at study entry, for a non-study systemic antibacterial (for concomitant infection) to which the target pathogen is susceptible. 26.Previous systemic antibacterial therapy for the treatment of Gram-positive cSSTIs for more than 24 hours within 48 hours prior to the day of first infusion of study drug unless: the infecting Gram-positive pathogen is intermediate or resistant in vitro to the previous antibacterial therapy; or the previous antibacterial therapy was administered for 3 or more calendar days with either worsening or no improvement in the clinical signs and symptoms of cSSTI, and was not vancomycin or SSP.

研究者

发起方

ovartis Pharma AG

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