A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 484
- 试验地点
- 2
- 主要终点
- Time to clinical improvement
研究概览
简要总结
The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study.
The main questions are:
- When someone is hospitalized with a severe influenza infection, does baloxavir help to reduce the time needed to recover?
- Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu?
- Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu?
- Can baloxavir reduce duration of contagiousness?
To be able to measure the above, the investigators will compare two groups of patients: One group receiving baloxavir marboxil, the other group receiving a mock treatment called placebo.
Participants will:
- Take one single dose of baloxavir marboxil or placebo soon after hospitalization.
- Vital signs will be followed three times per day during hospital stay.
- Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation.
- Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment.
详细描述
Background: Influenza virus is a major source of seasonal outbreaks and is the leading candidate for a future pandemic. Each winter thousands of people are hospitalized with infection complications. The most at risk are the very young (< 5 years), the elderly (>65 years old) and those with a weak immune system. When a person is hospitalized because of the flu, it is not always clear if the administration of a specific medicine that fights the virus (called an antiviral) will help.
Most studies looked at antivral drug benefits among people with mild flu, who didn't need to be hospitalized. They found that if the antiviral is started early (up to two days after the symptoms started), it can make the symptoms go away a little faster. But for people in the hospital, especially if it's been more than two days since their symptoms started, it is not so sure if antiviral drugs still help. Clinical research involving patients hospitalized for disease complications is few and of lesser quality. While some indicate that early treatment might be beneficial, there is no scientific agreement about treatment benefits. Therefore, recommendations and antiviral prescription varies between hospitals and physicians.
In Switzerland two antiviral drugs are authorized to treat the flu: Tamiflu® and Xofluza®.
Study aims and methods: The goal of this industry-independent trial is to measure the benefits of Xofluza® compared to placebo (mock medication) in adult patients hospitalized for the flu.
Choice of the medication: The investigators chose Xofluza® instead of Tamiflu® because it is very simple to use (only a single pill instead of twice a day Tamiflu® for 5 days), it has fewer side effects and can be safely given to patients with a wide range of chronic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Participant or participant representative capable of giving signed informed consent.
- •Positive reverse transcriptase-polymerase chain reaction (RT-PCR) for influenza A and/or B confirmed on arespiratory tract sample.
- •Patient requiring hospitalization.
- •National Early Warning Score 2 (NEWS2) of ≥4 at planned randomization
排除标准
- •Ongoing pregnancy or breastfeeding (self-reported by the participant or diagnosed by the treating phyisician)
- •Known contraindication to baloxavir or to the placebo
- •Participant weighing < 40 kg
- •Patients already on NAI therapy for the current influenza episode for > 24 hours at the time of randomization.
- •Prior treatment with baloxavir for the current influenza epidose
- •Immunosuppression defined as 1) cancer treatment with significant negative effect on the immune system; 2) immunosuppressive therapy (treatments comprising a dose of ≥20 mg/day prednisone or equivalent when administered for ≥ 2 weeks, biological therapies, steroid sparing drugs); 3) HIV infection if CD4+ T cell count < 500/µL; 4) organ or stem cell transplantation; 5) patients on the waiting list for a transplant
- •Severe underlying respiratory comorbidity requiring long-term oxygenotherapy at home.
- •Severe disease requiring ICU care directly at hospitalization.
- •Severe hepatic insufficiency or any other severe medical condition when participation in the study puts the patient at risk according to the investigator's judgment.
- •History of inclusion in this study during a previous influenza season
- •Inclusion in another interventional study with an investigational drug 30 days before inclusion in the study.
- •Unability to consent or patient representative unable to consent.
研究组 & 干预措施
antiviral treatment
baloxavir marboxil
干预措施: Baloxavir Marboxil (Drug)
placebo
Pacebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to clinical improvement
时间窗: From treatment administration to hospital discharge or NEWS2 score of 2 or lower maintained for 24 h, whichever comes first, assessed up to day 90
The primary outcome is the time to clinical improvement, calculated from treatment administration, assessed by time to hospital discharge alive or time to a NEWS2 score of 2 or lower maintained for 24 h, whichever comes first.
次要结局
- Clinical status severity score(At 7 days post treatment administration)
- Duration of hospitalization(From treatment administration to hospital discharge, assessed up to day 90)
- Duration of Oxigen supplementation(From treatment administration to waining of oxygen therapy, assessed up to day 90 (in patients requiring oxygen).)
- In-hospital clinical failure(From treatment administration to the end of hospital stay, maximum 30 days after treatment administration)
- Mortality(From treatment administration during 90 days)
- Influenza-related complications(From treatment administration during 90 days)
- Antibiotic consumption(From treatment administration to the end of hospital stay, maximum 30 days after treatment administration)
- Quality of life(At day 90-days post treatment administration)
- Viral shedding(On day 3 after treatment administration.)
- Duration of infectious viral shedding(On day 3 post-treatment administration)
- Change in quality of life at D90(At day 90-days post treatment administration)
研究者
Dre Pauline Vetter
Senior staff physician
University Hospital, Geneva