A study to understand the effects of treating a respiratory infection caused by the respiratory syncytial virus (RSV) using drug PC786, in adults that have received a blood stem cell transplant.
- Conditions
- Respiratory Syncytial VirusMedDRA version: 20.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-001667-24-GB
- Lead Sponsor
- Pulmocide Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
regimen
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method