JPRN-UMIN000054071尚未招募3 期
Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3) - BOLT-P3
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 210
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
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Circulatory insufficiency with catecholamines at ERCP time. ICU need. Hypothermia below 35 degrees Celsius. Recurrent cholangitis within 3 months. Biliary stricture >= Bismuth 2 or unclear biliary block. Post-surgery anatomical changes like biliary-jejunal anastomosis. Pancreatitis per International Pancreatic Society/American Pancreatic Association: Upper abdominal pain, serum amylase/lipase >3x ULN, acute pancreatitis imaging. Cholecystitis by TG18: A (Murphy's sign/right upper quadrant issues) + B (fever >37.1 degrees Celsius, CRP >3.0 mg/dL, WBC >10,000 uL) + C (acute cholecystitis imaging). Hepatic abscess. Other infections. Pre-registration continuous antibiotics. Pre-registration ERCP complications (perforation, pancreatitis, bleeding, cholecystitis, sedation-related issues). Immunosuppression: A (>10 mg prednisolone), B (HIV), C (neutrophils <=1500 uL), D (recent hematopoietic stem cell transplantation). Pregnancy. Other exclusions by physician.
研究者
相似试验
进行中（未招募）
1 期
Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trialinfective endocarditisEUCTR2019-003358-10-ESCarmen Olmos Blanco298
进行中（未招募）
1 期
Short versus extended antibiotic treatment for fever during low white blood cell counts in hematology patients with fever of unknown origin.Febrile neutropeniaMedDRA version: 19.1Level: PTClassification code 10063581Term: Stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.1Level: LLTClassification code 10002969Term: Aplastic anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.1Level: LLTClassification code 10003999Term: BacteremiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: LLTClassification code 10007810Term: Catheter related infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: LLTClassification code 10028566Term: MyelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10062957Term: Catheter bacteraemiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10056520Term: Catheter site infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2014-001546-25-NLVU University Medical Center240
已完成
4 期
Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial.febrile neutropenia1001886510004018NL-OMON47609VUmc276
进行中（未招募）
1 期
Optimizing the antibiotic treatment of uncomplicated acute appendicitisncomplicated acute appendicitisMedDRA version: 20.1Level: LLTClassification code 10000677Term: Acute appendicitisSystem Organ Class: 100000004862EUCTR2015-003633-10-FITurku University Hospital552
终止
不适用
STudy of Antibiotic Treatment In Children with chronic cough (STATIC)ISRCTN88611534Royal Stoke University Hospital80