EUCTR2010-022487-12-DE进行中（未招募）不适用
A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection
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
- Cerexa, Inc
- 入组人数
- 215
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
- •1. Male or female, at least 18 years of age.
- •2. Have pyuria, defined as = 10 white blood cells (WBCs) per mm3 in unspun urine or = 10 WBCs per high
- •power field in spun urine.
- •3. A local urine Gram stain must demonstrate the presence of gram-negative bacilli.
- •4. Clinical signs and/or symptoms of cUTI defined as:
- •a. Acute pyelonephritis, as indicated by BOTH of the following:
- •i. Fever = 38.0ºC oral
- •ii. Flank pain or costovertebral angle tenderness
- •b. Complicated lower urinary tract infection, as indicated by at least one of the following symptoms AND at least
- •one of the following complicating factors:
- •i. Symptoms (at least one):
- •Frequency
- •Suprapubic pain
- •Acute hematuria
- •ii. Complicating factors (at least one):
- •Male gender
- •Current bladder instrumentation or indwelling urinary catheter (any tube, stent, or foreign body conduit that
- •extends from the inside to the outside of the body) that is expected to be removed during the course of IV study
- •drug administration
- •Obstructive uropathy (eg, nephrolithiasis, tumor, fibrosis) that is expected to be medically or surgically treated
- •during the course of IV study drug administration
- •Urogenital surgery (eg, prostatectomy, transurethral resections) within 7 days prior to administration of the first
- •dose of study drug
- •Functional or anatomical abnormality of the urogenital tract including anatomic
- •malformations or neurogenic bladder, or with a postvoid residual urine volume of at least 100 mL
- •5. Have a pretreatment baseline urine culture specimen obtained within 48 hours before start of administration of
- •the first dose of study drug.
- •NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows
- •the results of the baseline urine culture, but a local urine Gram stain must be performed and demonstrate the
- •presence of gram-negative bacilli prior to start of study drug.
- •6. The subject’s infection would require initial treatment with IV antibiotics.
- •7. The subject must require initial hospitalization to manage the cUTI by the standard of care.
- •8. Female subjects of child-bearing potential, including those who are fewer than 2 years post-menopausal,
- •must agree to, and comply with, using 2 highly effective methods of birth control (ie, condom plus spermicide,
- •combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a
- •vasectomized partner) while participating in this study. In addition, all women of childbearing potential must
- •agree to continue to use 2 forms of birth control throughout the study and for at least 30 days after administration
- •of the last dose of study drug.
- •9. Signed informed consent, willingness, and ability to comply with all study procedures and restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 143
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •1. History of any hypersensitivity or allergic reaction to any ß-lactam (eg, cephalosporins, penicillins,
- •carbapenems).
- •2. Requirement for concomitant systemic antibiotic or antifungal therapy for any reason.
- •EXCEPTION: Topical antifungal or a single oral dose of any antifungal for treatment of vaginal candidiasis.
- •3. Known urinary tract infection or colonization with Pseudomonas aeruginosa, methicillin-resistant
- •Staphylococcus aureus, or any Enterococcus species.
- •4. The cUTI is known to be caused by a pathogen resistant to doripenem.
- •5. Confirmed fungal urinary tract infection with a colony count = 103 CFU/mL.
- •6. Receipt of any amount of potentially therapeutic antibiotic therapy after the collection of the pretreatment
- •baseline urine culture and before administration of the first dose of study drug.
- •7. Receipt of more than 1 dose of a potentially therapeutic antibiotic agent for the treatment of the current cUTI
- •within 96 hours before obtaining the study-qualifying pretreatment baseline urine culture.
- •EXCEPTIONS: 1) Subjects who failed prior antibiotic treatment with a culture growing a pathogen resistant to
- •the prior treatment; 2) Subjects receiving UTI prophylaxis are eligible to enroll if all other eligibility criteria are
- •met, including obtaining a study-qualifying pretreatment baseline urine culture. These subjects must discontinue
- •oral antibiotic prophylaxis from the time the pretreatment baseline urine culture is obtained until after TOC.
- •8. Intractable UTI anticipated to require more than 10 days of study drug therapy.
- •9. Complete, permanent obstruction of the urinary tract.
- •10. Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter
- •that will not be removed during IV study drug administration.
- •11. Suspected or confirmed perinephric or intrarenal abscess.
- •12. Suspected or confirmed prostatitis.
- •13. Ileal loops or vesico-ureteral reflux.
- •14. Impairment of renal function including a calculated CrCl of < 30 mL/min, requirement for peritoneal dialysis,
- •hemodialysis or hemofiltration, or oliguria (< 20 cc urine output per hour over 24 hours).
- •15. Renal transplantation.
- •16. Evidence of immediately life-threatening disease, including, but not limited to, current or impending
- •respiratory failure, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive ketoacidosis), or acute cerebrovascular events.
- •17. Life expectancy less than 3 months
- •18. Evidence of significant hepatic, hematological, or immunologic disease or dysfunction determined by any of
- •the following:
- •Known acute viral hepatitis
- •Aspartate amino transferase or alanine amino transferase level greater than 5-fold the upper limit of normal or
- •total bilirubin greater than 3-fold the upper limit of normal
- •Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
- •Current or anticipated neutropenia defined as less than 500 neutrophils/mm3
- •Thrombocytopenia with platelet count less than 60,000 cells/mm3
- •Known infection with human immunodeficiency virus and either a CD4 count less than or equal to 200 cells/
- •mm3 at the last measurement or current diagnosis of another Acquired Immune Deficiency Syndrome-defining
- •Bone marrow-ablative chemotherapy or radiation therapy within the prior 3 months
- •Receiving > 20 mg of prednisone (or equivalent systemic corticosteroid) per day
- •19. Probenecid administration within 3 day
研究者
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