CTRI/2010/091/000686已完成2 期
A double-blind, randomized, comparator-controlled study to assess the safety, efficacy, and pharmacodynamics of two doses of ACHN-490 Injection administered intravenously (IV) in patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).
Achaogen, Inc.7000 Shoreline Court, Suite 372South San Francisco, CA 94080, USA0 个研究点目标入组 240 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Able to understand and provide written informed consent.
- •2. Age of ≥ 18 to ≤ 85 years
- •3. An estimated dry body weight (non-edematous or non-volume
- •expanded weight) of ≤ 100 kg.
- •4. Documented* or suspected cUTI/AP with clinical signs and
- •symptoms as specified below:
- •a. Presence of a complicated lower tract infection (cUTI),
- •manifested by at least TWO of the following
- •i. Fever (oral temperature of > 38.5°C or > 101.3°F), or
- •elevated WBC (>10,000/mm3, or left shift (> 15%
- •immature PMNs)
- •ii. Dysuria
- •iii. Pyuria (≥ 5 white blood cells (WBCs)/high power field
- •[hpf] in urine sediment plus positive leukocyte esterase
- •[LCE] on urinalysis)
- •iv. Increased frequency
- •vi. Lower abdominal pain
- •AND at least ONE of the following:
- •i. Indwelling catheter
- •ii. Urine residual volume of ≥ 100 mL (within the last
- •6 months) as previously determined by voiding
- •cystourethrogram (VCUG) or ultrasound or straight
- •catheterization immediately post void
- •iii. Neurogenic bladder (excludes dropped bladders without
- •documented residual volume)
- •iv. Urinary retention in men due to previously diagnosed
- •benign prostatic hypertrophy (BPH)
- •b. Presence of clinical signs and symptoms of an ascending tract
- •infection (acute pyelonephritis [AP]), manifested by both fever (oral
- •temperature of >38.5°C or > 101.5°F; see APPENDIX 8), or
- •elevated WBC (>10,000/mm3, or left shift (> 15% immature PMNs)
- •and lower back/flank pain,
- •AND at least TWO of the following:
- •i. Costovertebral angle tenderness
- •iii. Chills
- •iv. Dysuria
- •v. Pyuria (≥ 5 WBCs/hpf in urine sediment plus positive
- •LCE on urinalysis)
- •vi. Increased urinary frequency
- •vii. Urgency
- •viii. Vomiting
- •*Documented cUTI/AP is defined by a positive pre-randomization
- •urine culture with a defined urinary bacterial pathogen.
- •5. Expectation that patients with indwelling catheters will have the
- •catheter removed or replaced (if removal is not clinically
- •acceptable) before or as soon as possible, but not longer than
- •12 hours, after randomization.
- •6. Normal renal function at Screening as estimated by creatinine
- •7. Women of childbearing potential: negative pregnancy test before
- •randomization, not breastfeeding, and using a highly effective
- 另有 15 项未显示
排除标准
- •(1) Patients with any of the following conditions: underlying renal disease (excluding indication cUTI/AP), myasthenia gravis, parkinsonism, or other neuromuscular disorder (2) Severe blood in the urine requiring intervention other than study drug (3) Urinary tract surgery or urinary tract surgery planned during the study period (4) Known non-renal (excluding bacteremia) source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization (5) Signs of severe sepsis (6) Pregnant or breastfeeding women (7) History of epilepsy or known seizure disorder (8) Receipt of disulfiram (9) Receipt of any investigational medication during the last month prior to randomization (10) Prior exposure to ACHN-490 Injection (11) Treatment with another antibiotic within 48 hours prior to randomization (12) Treatment with fluoroquinolone or bladder irrigation (13) Known history of human immunodeficiency virus (HIV) infection and current or previous CD4 count < 200/mm3 (14) Presence of immunodeficiency or an immunocompromised condition and use of systemic corticosteroids (15) Presence of neutropenia (16) History of hearing loss with onset before the age of 40 years (16) At risk for serious drug interactions because of concomitant medications [e.g., class IA (e.g., quinidine, procainamide, or Class III (e.g, amiodarone, sotalol)antiarrhythmic agents] (17) A QTc (Bazett's)> 440 msec (18) Known hypersensitivity to ACHN-490 Injection, and other aminoglycosides, levofloxacin, other fluoroquinolone antibiotics (19) An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator.
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