EUCTR2018-001667-24-GB进行中（未招募）1 期
A double blind, placebo-controlled study to assess the anti-viral effect, safety and tolerability of inhaled PC786 for the treatment of acute respiratory syncytial virus (RSV) infection in adult hematopoietic stem cell transplant recipients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Any potential study subject must satisfy all of the following criteria to be
- •eligible to enter the study. The subject is/has:
- •1.Received an allogeneic or autologous HSCT using any conditioning
- •2.Experienced new onset of at least one of the following respiratory
- •symptoms =5 days before study Day 1: Nasal congestion or stuffiness, runny nose (rhinorrhoea), cough, or sore throat OR worsening of at least one of these symptoms, if these symptoms are chronic (i.e., associated with a prior diagnosis, such as chronic rhinorrhoea, seasonal allergy or chronic lung disease) OR wheezing, sputum production, pleuritic chest pain, increased respiratory rate, signs on chest auscultation, hypoxia, increased supplemental oxygen requirement or new infiltrates on chest
- •X-ray or computerised tomography thorax
- •3.A positive RSV diagnostic test result on a sample collected from the nose or pharynx =2 days before Day 1 (may be =3 days before Day 1
- •only if the sample is collected on a Friday)
- •4.Provided written informed consent
- •5.Aged =18 years of age at the time of consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Any potential study subject who meets any of the following criteria below will be excluded from participating in this study.
- •The subject:
- •1.Is intubated and requires invasive ventilation OR is likely to require invasive ventilation in the next 3 days
- •2.Has received any investigational RSV vaccine after HSCT
- •3.Has received any monoclonal anti-RSV antibodies within 4 months or 5
- •half-lives before screening, whichever is longer
- •4.Requires treatment (or is known to require treatment) with intravenous ribavirin prior to subject being randomised in the study
- •5.Is documented to be positive for parainfluenza within 7 days before the screening visit
- •6.Is documented to be positive for influenza on a sample collected from the nose or pharynx =2 days before Day 1
- •7.Has clinically significant bacteraemia or fungaemia within 7 days before screening that has not been adequately treated
- •8.Has clinically significant bacterial, fungal, or viral pneumonia (due to a virus other than RSV) within 2 weeks before screening that has not been adequately treated
- •9.Is precluded from participating in this study as a result of treatment with another investigational drug or participation in another clinical trial
- •10.If female, is pregnant, lactating or breast feeding
- •11.Has any other disease or condition which in the Investigator's medical opinion would preclude the subject's participation in a clinical trial
- •12.Is receiving an antiretroviral protease inhibitor
- •13.Has chronic, active hepatitis infection
- •14.Has any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the subject from participation in the study
- •15.Is employed by or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site or any contract research
- •organisation involved in the study
研究者
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