CTRI/2024/05/067164尚未招募3 期
A Phase 3, randomized, double-blind, double-dummy, multicenter, multinational study to assess the efficacy and safety of orally administered tebipenem pivoxilhydrobromide (TBP-PI-HBr) compared to intravenously administered imipenemcilastatinin patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)
PSI CRO Pharma India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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. Have a diagnosis of cUTI or AP.
- •2. Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following:
- •a. at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment
- •b. at least 10 WBCs per millimeters cubed in unspun urine.
- •c. positive leukocyte esterase (LE) on urinalysis Note: Participants may be randomized and administered study drug prior to knowledge of urine culture results, but pyuria must be documented.
- •3. Expectation, in the judgment of the Investigator, that the participant will survive with effective antimicrobial therapy and appropriate supportive care for the anticipated duration of the study.
排除标准
- •1. Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy.
- •2.Gross hematuria requiring intervention other than administration of study drug or removal or placement of urinary tract instrumentation.
- •3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.
- •4. Creatinine clearance (CrCl) of =30 milliliters per minute, as estimated by the Cockcroft-Gault formula.
- •5. Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI or AP.
- •6. Receipt of more than a single dose of a potentially effective antimicrobial within 72 hours prior to study randomization.
- •7. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT)clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).
- •8. Pregnant or lactating women.
- •9. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
- •10. History of proven or suspected Clostridioides difficile associated diarrhea.
- •11. History of human immunodeficiency virus (HIV) infection.
- •12.QT interval corrected using Fridericias formula (QTcF) more than 480 milliseconds (msec) based on screening ECG.
- •13. History of known genetic metabolism anomaly associated with carnitine deficiency.
- •14. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.
研究者
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