JPRN-jRCT2080221955未知3 期
A Phase 3, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
适应症
试验速览
- 阶段
- 3 期
- 发起方
- AstraZeneca
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
- 年龄范围
- >= 18age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •18 to 90 years of age inclusive
- •- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
- •- Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
- •- Denmonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis.
排除标准
- •- Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem
- •- Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
- •- Patient is receiving homodialysis or peritoneal dialysis or had a renal transplant
- •- Patient is immunocompromised
- •- Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk or mortality
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of bimekizumab compared to placebo and an active comparator in adult subjects with moderate to severe chronic plaque psoriasisModerate to Severe Chronic Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-003425-42-ITCB Biopharma SR567
进行中（未招募）
不适用
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction CancerAdvanced MET-Positive Gastric, Lower Esophageal or Gastroesophageal Junction AdenocarcinomaMedDRA version: 16.0Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: LLTClassification code 10017766Term: Gastric cancer stage IV NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004923-11-HUAmgen Inc450
进行中（未招募）
1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- And Active-Controlled Study Followed By A Placebo-Controlled Maintenance Period And Open-Label Follow-Up To Evaluate The Efficacy And Safety Of Certolizumab Pegol In Subjects With Moderate To Severe Chronic Plaque Psoriasis - CIMPACTMedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000018190Plaque PsoriasisEUCTR2014-003492-36-GBCB Biopharma, SPR561
进行中（未招募）
1 期
Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Diseasemoderately to severely active Crohn’s diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2018-004614-18-SKEli Lilly and Company1,150
进行中（未招募）
不适用
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction CancerAdvanced MET-Positive Gastric, Lower Esophageal or Gastroesophageal Junction AdenocarcinomaMedDRA version: 17.0Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10017766Term: Gastric cancer stage IV NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004923-11-BGAmgen Inc600