EUCTR2011-000484-28-ES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. - A study of GSK2251052 therapy in treatment of febrile complicated lower urinary tract infections.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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:subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •Italian female subjects: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. Additionally, the subject agrees to one of the methods listed in the protocol for avoidance of pregnancy during the entire study treatment period:
- •2.Subject requires hospitalisation and has clinical signs and symptoms of lower cUTI or yelonephritis(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/?L(or >5/highpower
- •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
- •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
- •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
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the
- •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 that will not be removed 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
- •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 moderate to severe impairment of renal function
- •including: a calculated creatinine clearance (CrCl) of ?50 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
- •6. Subjects with asymptomatic lower cUTI, such as subjects with spinal
- •cord injury with lower cUTI or with a neurogenic bladder that are not
- •able to perceive symptoms or subjects with symptoms of neurogenic
- •hyper-reflexive bladder 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 (including acute hepatic failure, respiratory failure or septic
- •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.
- •13. Subject has a known platelet count less than 75,000 cells /mm3
- 另有 7 项未显示
研究者
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