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 - LRS114688

GLAXO SMITHKLINE0 个研究点目标入组 210 人开始时间: 2011年12月20日最近更新: 2014年1月27日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: GLAXO SMITHKLINE
入组人数: 210

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

•Italian female subjects: In Italy, a female subject will be eligible for inclusion in this study only if they are off non-childbearing potential.1. Adult subjects aged at least 18 years. N.B. Females of non-childbearing or childbearing potential may be enrolled. It is not contraindicated to enrol females of childbearing potential, however, they must have a a negative pregnancy test at study entry and must have practiced adequate contraception for at least 30 days prior to study entry. (see protocol list) 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, exceptions would be; i. Afebrile subjects with lower cUTI who have a white blood cell count (WBC) =15,000 cells/mm3 ii. Afebrile subjects with a lower cUTI following requiring parenteral therapy due to a specific indication e.g. • Before and during an operative procedure, when oral antibiotics are not indicated • Or in cases where the cUTI is suspected to be due to a pathogen resistant to current oral antibiotics, and at least two of the following UTI symptoms including dysuria, frequency, urgency or suprapubic pain, with the presence of a complicating factor: iii. Male gender; iv. Current bladder instrumentation or indwelling urinary catheter that has to be removed two days before the end of IV study drug administration; v. Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;vi. Urogenital surgery within 7 days preceding administration of the first dose of study drug; vii. 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 or spun MSU or catheter urine sample. 5. Subject has provided a pre-therapy urine specimen obtained within 48 hours prior to the start of therapy, which when cultured has grown at least one and not more than two Gram-negative uropathogens at =105 CFU/mL. a. A subject may be enrolled before the results of the pre-therapy urine culture is known, but the subject should be withdrawn from the study if the culture does not yield at least one but not more than two qualifying Gram-negative uropathogens at =105 CFU/mL or if the culture yields Gram-positive uropathogens. b. A subject with lower cUTI or pyelonephritis (complicated or uncomplicated) who has failed a previous antibacterial treatment regimen is eligible provided a urine specimen is positive for on

排除标准

•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 b. Complete permanent obstruction of the urinary tract; c. A permanent indwelling catheter or comparable instrumentation including nephrostomy that will not be emoved during IV study drug administration; 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 = 103 fungal CFU/mL); g. A UTI suspected or confirmed to be due to a Gram-positive uropathogen(s), with =105 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 >20. 4. Subject has known severe impairment of renal function including: a calculated creatinine clearance (CrCl) of less equal than 51 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 Gramstained 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 29 10. Subject has evidence of known or pre-existing severe hepatic disease. 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/mm3.13. 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 transplantation, hematological malignancy, and/or immunosuppressive therapy , including high-dose corticosteroids ( 15. Subject has participated in any investigational drug or device study within 30 days of study entry or within 5 half-lives, whichever is longer. 16. Subject has previously received treatment with GSK2251052. 17. Subject has a prior history of seizures or has a CNS abnormality predisposing them to seizures or has a lowered seizure threshold and/or is using concomitant medications with seizure potential. 18. Subject requires probenicid or valproic acid medications. 19. Subject with a history of moderate or severe hypersen

研究者

发起方

GLAXO SMITHKLINE

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