jRCTs071200034已完成不适用
A randomized, controlled study of baloxavir marboxil compared with oseltamivir in patients with influenza virus infection aged 75 years and older
未提供0 个研究点目标入组 100 人开始时间: 2021年1月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Duration of influenza disease
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 75age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients for whom voluntary written consent to participate in the study can be obtained personally
- •Patients aged 75 years or older at the time of informed consent
- •Presence of at least one each of the following general and respiratory symptoms associated with influenza, with severity of moderate or higher (with the exception of chronic symptoms or other symptoms that existed 30 days before the onset of influenza) at the time of informed consent and persisting at screening
- •a. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue)
- •b. Respiratory symptoms (cough, sore throat, or nasal congestion)
- •Patients with fever of =>37.5 degrees Celsius (axillary) within 12 hours before pre-dose examination (screening )
- •Influenza-positive patients with rapid influenza diagnostic test at screening
- •*If a rapid influenza diagnostic test or any other influenza virus detection method has been already performed in routine clinical practice within 48 hours of onset as inclusion criteria 6), the results can be determined.
- •Patients in whom the time interval between the onset of symptoms and the pre-dose examination is 48 hours or less. Symptomatic onset is defined as follows:
- •a. Time of the first increase in body temperature (an increase by at least 1 degrees Celsius from normal body temperature)
- •b. Time when the patient newly experiences at least one general or respiratory symptom
排除标准
- •Patients with severe influenza requiring hospitalization for treatment1) Patients with severe influenza requiring hospitalization for treatment
- •Patients who are allergic to baloxavir /oseltamivir or have a history of clinically relevant intolerance to baloxavir /oseltamivir
- •Patients who are severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive or with suspected coronavirus disease 2019 (COVID-19)
- •Patients who are unable to swallow baloxavir tablets or oseltamivir capsules
- •Patients with any concurrent infection requiring systemic antimicrobial treatment at the time of screening
- •Patients with poorly controlled metabolic disease (including diabetes)
- •Patients on dialysis and patients with severe renal impairment (defined as eGFR of <30 mL/min/1,73m2)
- •Patients with congestive cardiac failure receiving pharmacological treatment
- •Patients with any major cardiovascular disease, central nervous system disease, endocrine disorder (thyroid function, adrenal function), hepatitis, or liver cirrhosis requiring hospitalization
- •Patients with malignancy receiving chemotherapy or immunotherapy
- •HIV-infected patients
- •Patients in an immunosuppressed state after organ or bone marrow transplant
- •Patients receiving continuous systemic prednisolone at >20 mg or equivalent doses of corticosteroids
- •Patients who received baloxavir marboxile (Xofluza), peramivir (Rapiacta), Laninamivir (Inavir), oseltamivir (Tamiflu, Oseltamivir Capsules 75mg "Sawai"), zanamivir (Relenza), or amantadine (Symmetrel) within 14 days before screening
- •Patients who will require prohibited concomitant medication during the study period in the opinion of the investigator/subinvestigator
- •Patients who are participating other clinical studies
- •Patients who had participated in this clinical study
- •Patients that the investigator/subinvestigator deems difficult to be participated to the study
结局指标
主要结局
Duration of influenza disease
Time to improvement of influenza symptoms (adjusted for existing symptoms)
次要结局
- Time to alleviation of the seven influenza symptoms
- Time to improvement of the four general symptoms
- Time to improvement of the three respiratory symptoms
- Time to resolution of fever to normal temperature
- Proportion of patients with resolution of fever to normal temperature at each time point of evaluation
- Body temperature at each time point of evaluation
- Influenza virus serum antibody titers at each time point of evaluation
- Time to resolution of gastrointestinal symptoms
- Time to improvement of each symptom of influenza
- Proportion of patients who underwent additional treatments or procedures for underlying respiratory disease
- Changes in respiratory function parameters(up to 2 weeks after the start of treatment)
- Time to return to pre-influenza health
- Requirement for systemic antimicrobial use for influenza secondary infections
- Incidence of influenza-related complications
- Household infection rate for influenza after the start of the study
研究者
相似试验
尚未招募
不适用
Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with InfluenzaD007251InfluenzaJPRN-jRCT1051180014Kato Kentaro40
已完成
不适用
open-label, active-controlled study of baloxavir in pediatric patients with influenzainfluenzajRCTs011200011200
已完成
3 期
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza SymptomsInfluenzaNCT06774859Hoffmann-La Roche100
已完成
3 期
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like SymptomsInfluenzaNCT03629184Hoffmann-La Roche173
已完成
不适用
Double-blind Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with InfluenzaInfluenzaJPRN-UMIN000034870Kitano Hospital, Tazuke Kofukai Medical Research Institute. Department of Pediatrics40