EUCTR2011-006041-14-PL进行中（未招募）不适用
A Multi-Dose, Double-Blind, Double-Dummy, Active Control, Randomized Clinical (Phase II) Study of Two Dosing Regimens of Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis Requiring Hospitalisation
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
- 258
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
- •All subjects MUST:
- •1.be male or female subjects = 18 years of age.
- •2.if a female
- •a.and subject is of childbearing potential, must have documented use of using an effective contraceptive method (such as IUD, hormonal birth control, condom and spermicidal jelly, etc.) during the study, a documented negative serum pregnancy test and must be non-lactating.
- •b.subject is of non-childbearing potential, must be post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
- •3.If a male, should agree to use reliable birth control methods (contraception or other barrier device) during study participation.
- •4.have at least two of the following (acute?) signs and symptoms
- •a.Chills or rigors or warmth associated with fever (e.g., oral temperature greater than 38 degrees Celsius)
- •b.Flank pain (pyelonephritis) or pelvic pain (cUTI)
- •c.Nausea or vomiting
- •d.Dysuria, urinary frequency, or urinary urgency
- •e.Costo-vertebral angle tenderness on physical examination
- •of complicated lower urinary tract infection including acute complicated and uncomplicated pyelonephritis (cPN or uPN) (see 5.3).
- •5.provide one pre-treatment adequate urine culture (the urine culture must return a positive culture in order for the subject to remain eligible for the study) (for males: midstream clean catch, for females: in-out catheterisation or midstream clean catch) which must be provided within 24 hours before the start of administration of the first dose of study drug, defined as = 105 CFU/mL (in case of pyelonephritis = 104 CFU/mL). Patients may be admitted to the study pending baseline urine culture results.
- •NOTE: Because biofilms on indwelling catheters (e.g., Foley catheters) are more likely to be present after the catheter has been in place for a period of time, samples should be collected following the placement of a new catheter. If the placement of a new catheter is contraindicated or is not feasible, specimens should be collected using aseptic techniques with the urine obtained through a properly disinfected collection port. Urine samples should never be obtained from the collection bag.
- •If the subject’s pre-treatment culture shows the presence of a ciprofloxacin resistant pathogen or negative urine culture (defined as < 104 cfu/mL of causative pathogens), the Investigator’s medical judgement will determine whether or not the subject should continue in the study:
- •in case of resistant pathogen, the Investigator has to decide according to clinical signs and symptoms whether the subject can stay in the study.
- •in the case of a NEGATIVE culture (see above) the subject must be switched to standard care, because the inclusion criterion was not fulfilled.
- •6.have pyuria (i.e. a dipstick analysis positive for leukocyte esterase or at least 10 white blood cells per cubic millimetre [1 µl])
- •7.be considered ill enough to be hospitalized and require initial parenteral therapy to manage cUTI and/or acute pyelonephritis by the standard of care.
- •8.provide written informed consent to participate in the study.
- •9.be willing and able to comply with all study procedures and activities.
- •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 232
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Uncomplicated cystitis in females.
- •2. Failed previous antibiotic treatment within the last 4 weeks due to culture confirmed fluoroquinolone resistant pathogens.
- •3. Having Ileal loops, urinary diversion with bowel segments or suspected or confirmed vesico-ureteral reflux, suspected or confirmed perinephric or intrarenal abscess (if an abscess is suspected an ultrasound should be performed to confirm and exclude).
- •4. History of renal transplant any permanent complicating factors of the urinary tract (including complete obstruction, suspected or confirmed
- •prostatitis or epididymitis) which cannot be effectively treated during the therapy of the infection.
- •5. Indwelling urinary catheters expected to remain in place after therapy has been completed.
- •6. The urinary tract infection or any other concomitant bacterial infection that requires systemic antibiotic therapy (in addition to the study treatment) at the time of randomisation. Antibiotics with only grampositive
- •activity are permitted.
- •7. Any infection that, in the opinion of the Investigator, would be considered intractable and likely to require more than 10 days of study drug therapy.
- •8. Any recent use (e.g., within 48 hours before the first dose of study medication) of an antimicrobial therapy with a drug that has activity in the treatment of urinary tract infection.
- •9. Having been exposed to any fluoroquinolone in the 30 days before Day 1 (study enrolment), previous participation in a finafloxacin clinical trial or participation within the last 30 days in any other clinical study in
- •10. Known uncontrolled condition of hypertension or symptomatic hypotension, known ischaemic heart disease or history of myocardial infarction (within 12 months before study enrolment), coronary
- •arterybypass surgery or percutaneous transluminal coronary angioplasty.
- •11. Significantly immunocompromised (defined as a WBC < 1000) and/or having a known infection with human immunodeficiency virus (HIV/AIDS), any haematological malignancy, bone marrow transplantation, or current immunosuppressive therapy (including but not limited to cancer chemotherapy, or medications for prevention of organ transplantation rejection).
- •12. Any concomitant psychiatric, neurological or behavioural disorder, including epilepsy or other lesions of the central nervous system sufficient in the opinion of the Investigator to prevent or compromise the subject´s particiaption in the sudy.
- •13. Any known concomitant bacterial or fungal sexually transmitted disease.
- •14. Having, in the opinion of the Investigator, any clinically significant serious or unstable physical illness likely to impact on the subject's wellbeing or the conduct and analysis of the study, including, but not
- •limited to, acute hepatic failure, respiratory failure, severe, persistent diarrhoea and septic shock.
- •15. Any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, including, but not limited to moderate (including estimated creatinine clearance of 20 - 39
- •mL/min) or severe impairment of renal function (including an estimated creatinine clearance of < 20 mL/min), requirement for peritoneal dialysis, haemodialysis or haemofiltration, or oliguria.
- •16. Any malignant disease or a history of malignant neoplasm requiring a treatment with immune suppressive properties within the last 6 months before baseline.
- •17. Known history of drug abuse.
- •18. Clinically abnormal haematology, biochemistry and urinaly
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