Rapid Assay for Sick Children with Acute Lung infection Study
Research type
Research Study
Full title
Rapid Assay for Sick Children with Acute Lung infection Study
IRAS ID
277039
Contact name
Nazima Pathan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Clinicaltrials.gov Identifier
NCT04233268, clinicaltrials.gov
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Children admitted to the paediatric intensive care unit (PICU) for chest infection are routinely given strong antibiotics. Chest infection is often viral so antibiotics will not help, but it can be hard to tell this in sick children. The current tests to detect bacteria take several days, and antibiotics are given until results are available. This study is trialling a new bacteria test called TaqMan array, which is hoped to provide faster results. This may mean less antibiotics need to be used on sick children with chest infection.\n\nChildren will be included in the study if they are aged less than 16 years old, receiving the help of a breathing machine, and are receiving antibiotics for chest infection. Secretions will be taken from the breathing tube for routine tests, but some of the sample will be set aside for this study. Half a teaspoon of blood will also be taken, but only if the child has a line in place to do this. \n\nThe child’s carers will be approached by the research team within 48 hours for permission for the samples to be used in the research project. They will also be asked for permission for the research team to use anonymised data about the child’s admission to the intensive care unit. This data will be used in future reports and publications.\n\nThe intensive care doctors and infection specialists will be given the result of the TaqMan array test. We will give the doctors a survey to see if the test helped them with any decisions relating to the child’s treatment. More in depth testing of the secretion and blood samples will also take place for the study, but this testing will take place over many months following the child’s stay in intensive care. [COVID-19 amendment 08/04/2020] 1. We would like to add a cohort of pregnant women (admitted at time of delivery, at 24 weeks or more gestation) and their babies. My hospital is seeing a surge in cases of pregnant women with suspected COVID-19 and we are concerned about the risk to newborn infants in terms of vertical transmission of infection, potential impact on gestation at delivery, health of the newborn and the implications for postnatal transmission.\n2. We would like to add 2 additional timepoints for blood samples (minimising the volume to be taken from newborn babies). To be taken only if routine clinical samples are planned. We would like to gain a better understanding of the impact of host immune responses in severity of disease so we would like to take an extra two blood samples in the week following admission. I attach the amended protocol and the maternity documentation. I attach the amended protocol that has been developed in consultation with the departments of Obstetrics and Neonatology - I have added the relevant staff as co-investigators.\nI also attach the Patient information sheet and Consent for pregnant women (we would plan to consent the baby(or babies) separately to the mother) and GP letter.\n\n\n \n\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
20/YH/0089
Date of REC Opinion
26 Mar 2020
REC opinion
Further Information Favourable Opinion