EUCTR2013-004556-38-PL进行中（未招募）不适用
A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared with Levofloxacin in Complicated Urinary Tract Infections - IGNITE2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 840
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 and female subjects with either:
- •a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR
- •b. cUTI with at least one of the following conditions associated with a risk for developing cUTI:
- •i. Indwelling urinary catheter
- •ii. Urinary retention (at least approximately 100 mL of residual urine after voiding)
- •iii. History of neurogenic bladder
- •iv. Partial obstructive uropathy (eg, nephrolithiasis, bladder stones, and ureteral strictures)
- •v. Azotemia of renal origin (not congestive heart failure [CHF] or volume related) such that the serum blood urea nitrogen [BUN] is elevated (> 20 mg/dL) AND the serum BUN:creatinine ratio is < 15
- •vi. Surgically modified or abnormal urinary tract anatomy (eg, bladder diverticula, redundant urine collection system, etc.) EXCEPT urinary tract surgery within the last month (placing of stents or catheters is not considered to be surgical modification)
- •2. At least 18 years of age
- •3. Able to provide informed consent
- •4. At least two of the following signs or symptoms:
- •a. Chills, rigors, or warmth associated with fever (oral, rectal, tympanic, or by temporal artery temperature > 100.4°F / 38°C) or hypothermia (oral, rectal, tympanic, or by temporal artery temperature < 95°F / 35°C)
- •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
- •5. Urine specimen with evidence of pyuria
- •a. Dipstick analysis positive for leukocyte esterase (where positive result is at least ++” as indicated on the urine dipstick provided in the laboratory kit), OR
- •b. At least 10 white blood cells (WBCs) per cubic millimeter, OR
- •c. = 10 WBCs per high power field
- •6. The following subjects who have received previous/ongoing antibiotics will be eligible for enrollment:
- •a. Subjects with cUTI and a known baseline pathogen who have received prior antibiotic therapy for a minimum of 72 hours, but who are deemed clinical and microbiological failures (urine culture obtained after 72 hours of therapy with > 10,000 colony-forming units [CFU]/mL)
- •b. Subjects with suspected acute cUTI who have received a single dose of effective non-study antibiotics for the acute cUTI in the previous 24 hours
- •7. Subjects must agree to use a highly reliable method of birth control
- •a. Male subjects must agree to use an effective barrier method of contraception during the study and for 30 days following the last dose if sexually active with a female of childbearing potential
- •b. Female subjects must not be pregnant or nursing. For females of childbearing potential, subjects must commit to either:
- •i. Use at least two medically accepted, effective methods of birth control (eg, condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant /patch, injections, approved cervical ring, etc.) during study drug dosing and for 30 days following last study drug dose, OR
- •ii. Sexual abstinence
- •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 756
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in subjects with cUTI, including:
- •a. Subjects with a history of a levofloxacin-resistant urinary tract infection
- •b. Likely to receive ongoing antibacterial drug prophylaxis prior to the LPT visit (eg, subjects with vesiculo-ureteral reflux)
- •c. Use of systemic antibiotics effective in cUTI within 72 hours prior to enrollment except under circumstances meeting Inclusion Criterion 6
- •2. Likelihood that the subject will not survive at least through the duration of the study (approximately 4 weeks)
- •3. Hypotension, systolic blood pressure = 90 mmHg
- •4. Complicated pyelonephritis with complete obstruction or known or suspected renal or perinephric abscess, emphysematous pyelonephritis, OR
- •Any condition likely to require surgery to achieve cure (this does NOT include procedure to place cathertors or obtain diagnosis)
- •5. Known or suspected urinary fungal infection
- •6. Uncomplicated lower urinary tract infections
- •7. Suspected or confirmed active prostatitis, or currently under treatment for prostatitis
- •8. Subjects with high risk for cUTI due to Pseudomonas sp. (eg, history of prior cUTIs due to Pseudomonas, = 20 mg QD prednisone or equivalent steroid, and other risk factors as perceived by the investigator)
- •9. History of renal transplantation
- •10. Presence of an ileal loop
- •11. Any history of trauma to the pelvis or urinary tract occurring within 30 days of screening
- •12. Indwelling urinary catheters present at screening expected to remain in place after IV therapy has been completed (eg, nephrostomy tubes, stents, urethral and suprapubic catheters)
- •13. Known concomitant HIV infection with CD4 counts below 200 cells/µL within the last six months, or an AIDS defining diagnosis within the last six months
- •14. Neutropenia (ANC < 1,000 PMNs/µL)
- •15. Creatinine clearance of < 50 mL/min as estimated by the Cockcroft-Gault equation (eCCr) (1):
- •eCCr [mL/min]=((140-Age [yrs] ) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg/dL])
- •Note: The following exclusion criterion may be substituted for that based on Cockcroft-Gault to determine eligibility: glomerular filtration rate < 50 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease equation (eGFR) (2)
- •16. Removed in Global Protocol Version 3.0
- •17. Participation in a study with an experimental drug within 30 days
- •18. Known or suspected hypersensitivity to tetracyclines or fluoroquinolones
- •19. Any other unstable or clinically significant concurrent medical condition (ie, immunosuppressive therapy, chemotherapy, or class IV heart or lung disease) that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol
研究者
相似试验
进行中（未招募）
不适用
Multicenter Study to Assess the Efficacy and Safety of a study drug, Eravacycline, Compared with an approved drug, Ertapenem, in Complicated Intra-abdominal InfectionsComplicated Intra-abdominal InfectionsMedDRA version: 14.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 100000004862EUCTR2013-001913-34-LVTetraphase Pharmaceuticals, Inc.536
进行中（未招募）
不适用
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract InfectionsComplicated urinary tract InfectionsMedDRA version: 16.1Level: LLTClassification code 10046576Term: Urinary tract infection, site not specifiedSystem Organ Class: 100000004862EUCTR2013-004556-38-ITTetraphase Pharmaceuticals, Inc.840
进行中（未招募）
不适用
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract InfectionsComplicated urinary tract InfectionsMedDRA version: 16.1Level: LLTClassification code 10046576Term: Urinary tract infection, site not specifiedSystem Organ Class: 100000004862EUCTR2013-004556-38-LVTetraphase Pharmaceuticals, Inc.840
进行中（未招募）
1 期
Multicenter Study to Assess the Efficacy and Safety of Eravacycline Compared with Ertapenem in Complicated Urinary Tract InfectionsEUCTR2016-002207-26-ATTetraphase Pharmaceuticals, Inc.1,200
进行中（未招募）
不适用
Multicenter Study to Assess the Efficacy and Safety of a study drug, Eravacycline, Compared with an approved drug, Ertapenem, in Complicated Intra-abdominal InfectionsComplicated Intra-abdominal InfectionsMedDRA version: 16.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 100000004862EUCTR2013-001913-34-LTTetraphase Pharmaceuticals, Inc.536