CTRI/2013/03/003477招募中4 期
An exploratory, observational study to evaluate the efficacy and safety of daptomycin in treating neutropenic patients with fever due to known or suspected gram positive infections in adult hemato-oncology patients.
ovartis Healthcare Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Patients of either gender, above the age of 18 years, who have received atleast 1 dose on daptomycin
- •2.Hemato-Oncology patients with diagnosis of neutropenic fever
- •oTemperature 38.3 degrees C once OR greater than or equal to 38 degrees C twice within 12 hours
- •oAbsolute neutrophil count 500/cubic mm and greater than or equal to 1 of the following:
- •ï?§Mucositis
- •ï?§Concurrent skin or soft tissue infection
- •ï?§Indwelling catheter and/or suspected catheter infection
- •ï?§Recent quinolone prophylaxis
- •ï?§Positive blood cultures for gram-positive cocci before final identification Known Colonization with β-lactam resistant gram-positive organisms (commonly the nares or the skin)
- •ï?§Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise
- •oExpected duration of neutropenia greater than or equal to 3 days
- •3.Have a life expectancy of greater than or equal to 2 weeks.
- •4.Have performance status with an Eastern Cooperative Oncology Group score of less than or equal to 2.
- •5.Creatinine clearance greater than or equal to 30 mL/min
- •6.Negative pregnancy test [Note : Fertile patients must use effective double-method contraception]
- •7.No psychiatric disorders that would preclude study compliance, No HIV positivity.
- •8.No suspected meningitis or osteomyelitis.
- •9.No documented or suspected gram-positive pneumonia
- •10.No signs or symptoms of myopathy with creatine phosphokinase (CPK) elevation 1,000 U/L (5 times upper limit of normal [ULN]) [No CPK elevations 10 times ULN in patients with no signs or symptoms of myopathy]
- •11.No known sensitivity to daptomycin or product excipients
- •12.Patient is willing to participate in the study.
排除标准
- •1.Known allergic reaction to daptomycin or product excipients
- •2.Known to be infected with a daptomycin-resistant organism or a gram-negative organism and did not yet meet the criteria for the addition of antimicrobial therapy for the treatment of an infection caused by a gram-positive organism;
- •3.Suspected meningitis or osteomyelitis
- •4.Currently pregnant, were positive for serum human chorionic gonadotropin, or lactating
- •5.Have a creatinine clearance (CLCR) level of 30 ml per min; or on hemodialysis or continuous ambulatory peritoneal dialysis;
- •6.Psychiatric disorders with an inability to comply with study protocols;
- •7.Documented or suspected pneumonia caused by a gram-positive organism;
- •8.Life expectancy of 2 weeks;
- •9.Have rhabdomyolysis or a history of rhabdomyolysis or have signs and symptoms of myopathy with an elevation of the creatine phosphokinase (CPK) level of 1,000 U per liter (approximately five times the upper limit of normal); or reported signs or symptoms of myopathy and elevations of the CPK level of 10 times the upper limit of normal
- •10.Diabetic patient taking concurrent medication Piglitazone
- •11.No concurrent hydroxymethyl glutaryl coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin)
- •12.Hemoglobulin levels below 7gm per dl.
- •13.Patient unable or unwilling to follow or comply with all study-related procedures
- •14.Patient participating in another clinical study requiring follow-up examinations
- •15.Patients, who in the opinion of the Investigator is not suitable for this study regimen
研究者
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