EUCTR2016-002207-26-AT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of IV Eravacycline Compared with Ertapenem in Complicated Urinary Tract Infections - IGNITE 3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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 (e.g., 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 30 days (placing of stents or catheters is not considered to be surgical modification)
- •2. At least 18 years of age at time of consent
- •3. Able to provide informed consent. For subjects with diminished decision-making capacity and where applicable law permits, a Legally Authorized Representative may consent on behalf of a prospective subject to the subject's participation.
- •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 /
- •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. = 10 white blood cells (WBCs) per cubic millimeter, OR
- •c. = 10 WBCs per high power field
- •6. 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 (e.g., condom) during the study and for 14 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 (refer to section 11.4.1 for definition of nonchildbearing 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 14 days following last study drug dose,
- •c. 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 780
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 420
排除标准
- •1. Use of systemic antibiotics effective in cUTI within 72 hours prior
- •torandomization EXCEPT under the following circumstances:
- •a. Subjects with suspected acute cUTI who have received a single dose of effective non-study antibiotics for the acute cUTI
- •b. Signs and symptoms of cUTI developed while on the antibiotic for another indication
- •2. History of an ertapenem-resistant urinary tract infection within 1 year
- •3. Likely to require > 10 days of antibiotic treatment to cure the acute cUTI or likely to receive ongoing antibacterial drug prophylaxis prior to the FU visit (eg. Subjects with chronic vesiculo-ureteral reflux).
- •4. Unlikely to survive at least through the duration of the study
- •5. Hypotension, systolic blood pressure = 90 mmHg
- •6. Complicated pyelonephritis with complete obstruction or known or suspected renal or perinephric abscess, emphysematous pyelonephritis,
- •Any condition likely to require surgery to achieve cure (this does NOT include procedure to place catheters or obtain diagnosis)
- •7. Known or suspected urinary fungal infection
- •8. Uncomplicated lower urinary tract infections
- •9. Suspected or confirmed active prostatitis, or currently under treatment for prostatitis
- •10. 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)
- •11. History of renal transplantation
- •12. Presence of an ileal loop
- •13. Any history of trauma to the pelvis or urinary tract occurring within 30 days prior to consent
- •14. Indwelling urinary catheters present at screening which are not expected to be removed or replaced within 72 hours of randomization (eg, nephrostomy tubes, stents, urethral and suprapubic catheters).
- •15. Known concomitant HIV infection with CD4 counts below 200 cells/µL within six months prior to consent, or an AIDS defining diagnosis within six months prior to consent
- •16. Neutropenia (ANC < 1,000 PMNs/µL)
- •17. Participation in a study with an experimental drug or device within 30 days prior to consent
- •18. Known or suspected hypersensitivity to tetracyclines, carbapenems, or ß-lactams
- •19. History of seizures
- •20. Any other unstable or clinically significant concurrent medical condition (e.g., immunosuppressive therapy, chemotherapy, class IV heart or lung disease, end stage renal disease, or requiring hemodialysis) that would, in the opinion of the Investigator, jeopardize the safety of a subject and/or their compliance with the protocol
研究者
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