EUCTR2011-000484-28-GR进行中（未招募）不适用
A randomised, double-blind, dose-finding, multicenter study of the safety, tolerability, and efficacy of GSK2251052 therapy compared to imipenem-cilastatin in the treatment of adult subjects with febrile complicated lower urinary tract infections and acute pyelonephritis
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 210 人开始时间: 2011年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •1.Adult subjects aged at least 18 years.
- •N.B. Females of non-childbearing or childbearing potential may be enrolled. Females of childbearing potential must have a negative pregnancy test at study entry and must have practiced adequate contraception for at least 30 days prior to study entry. Additionally, the subject agrees to one of the following methods for avoidance of pregnancy during the entire study treatment period:
- •Abstinence; or,
- •Oral Contraceptive, either combined or progestogen alone, PLUS an additional barrier method [i.e., condom, occlusive cap (diaphragm or cervical/vault caps) or vaginal spermicidal agent (foam/gel/film/cream/suppository)]; or,
- •Injectable progestogen; or,
- •Implants of levonorgestrel; or,
- •Estrogenic vaginal ring; or,
- •Percutaneous contraceptive patches; or,
- •Intrauterine device (IUD) or intrauterine system (IUS) showing that failure rate is less than 1% in the IUD or IUS product label; or,
- •Has a male partner who is sterilized (vasectomy with documentation of azoospermia); or,
- •Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
- •Females are considered to be of non-childbearing potential if they have documented tubal ligation or hysterectomy; or are postmenopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory].
- •2.Subject requires hospitalisation and has clinical signs and symptoms of lower cUTI or pyelonephritis (complicated or uncomplicated) as defined below, that requires parenteral treatment only with a treatment course of a minimum of 5 days and a maximum of 14 days:
- •a. Lower cUTI – subjects must have documented fever defined as >38°C oral, >38.5°C tympanic or >39°C rectal, within the last 24 hours and at least two of the following UTI symptoms including dysuria, frequency, urgency or suprapubic pain, with the presence of a complicating factor:
- •i.Male gender;
- •ii.Current bladder instrumentation or indwelling urinary catheter that has to be removed two days before the end of IV study drug administration;
- •iii.Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
- •iv.Urogenital surgery within 7 days preceding administration of the first dose of study drug;
- •v.Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.
- •b.Acute pyelonephritis (complicated or uncomplicated): subjects must have documented fever defined as >38°C oral, >38.5°C tympanic or >39°C rectal, within the last 24 hours and flank pain or costovertebral angle tenderness (CVA). Complicating factors for pyelonephritis are the same as for complicated UTI.
- •3.Subject has pyuria (white blood cell [WBC] count > 10/µL (or >5/high-power field [HPF] in a conventional urinalysis) in unspun clean-catch midstream urine (MSU) or catheter urine sample or = 10 WBC/HPF in spun MSU or catheter urine).
- •4.Subject has Gram-negative organism(s) on direct examination of a Gram-stained specimen from unspun
排除标准
- •1.Concomitant infection requiring systemic antibacterial therapy other than study drugs at the time of randomisation.
- •2.Subject is known to have one or more of the following:
- •a.A urinary catheter that is not being removed during the study (or with an expectation that a catheter would be inserted during therapy with study drug and subsequently not removed during the study period; (intermittent straight catheterisation is acceptable)
- •b.Complete permanent obstruction of the urinary tract;
- •c.A permanent indwelling catheter or comparable instrumentation including nephrostomy;
- •d.Suspected or confirmed prostatitis;
- •e.Suspected or confirmed perinephric or intrarenal abscess;
- •f.A UTI suspected or confirmed to be fungal in origin (with = 10 to the power 3 fungal CFU/mL);
- •g.A UTI suspected or confirmed to be due to a Gram-positive uropathogen(s), with =10 to the power 5 Gram-positive organism CFU/mL;
- •h.A UTI known at study entry to be caused by a pathogen(s) resistant to the study antimicrobial agent;
- •i.Known ileal loops or vesico-ureteral reflux ;
- •j.Polycystic kidney disease.
- •3.Subject has an APACHE II score >30.
- •4.Subject has known severe impairment of renal function including: a calculated creatinine clearance (CrCl) of less than 41 mL/min; requirement for peritoneal dialysis, haemodialysis, or haemofiltration; oliguria (less than 20 mL urine output per hour over 24 hours);
- •5.Subject with an intractable lower cUTI requiring more than 14 Days IV treatment.
- •6.Subjects with asymptomatic lower cUTI, such as subjects with spinal cord injury with lower cUTI who are not able to perceive symptoms due to their injury.
- •7.Subject with lower cUTI or pyelonephritis (complicated and uncomplicated) who has received any amount of a potentially therapeutic antibiotic within the 96 h before providing the baseline urine culture specimen or prior to the start of the study.
- •8.Subject has Gram-positive organism(s) on direct examination of a Gram-stained specimen of spun/unspun MSU or catheter urine.
- •9.Subject is considered unlikely to survive the 4 6 week study period or has any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure, respiratory failure or septic shock).
- •10.Subject has evidence of known or pre-existing severe hepatic disease (Child-Pugh score of B or C).
- •11.Subject has a known baseline haemoglobin less than 10 g/dL ,haematocrit less than 30% and/or a known reticulocyte count of >5% (i.e., reticulocytes >5% of total RBC mass)
- •12.Subject has known neutropenia or is anticipated to develop neutropenia during the course of the study (i.e., new chemotherapy subject), with absolute neutrophil count less than 1000 cells/mm3 (subjects with neutrophil counts as low as 500 cells /mm3 are eligible if the reduction is due to the acute infectious process).
- •13.Subject has a known platelet count less than 75,000 cells /mm3 (subjects with platelet counts as low as 50,000 cells /mm3 are eligible if the reduction is historically stable).
- •14.Subject has an immunocompromising illness; including known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), organ (including bone marrow) transplantation, hematological malignancy, and/or immunosuppressive therapy , including high-dose corticosteroids (e.g., greater than 40 mg prednisone or equivalent per day for greater than two weeks).
- •15.Subject has participated in any investigational dru
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