P4 in PICU - Version 1
Research type
Research Study
Full title
A Case-Control Study of P4 for the Treatment of Children with Sepsis
IRAS ID
233523
Contact name
Laura Thompson
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
019540MMA16C, Novae Underwriting Limited Insurance Policy Number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A protein, P4, has been shown to improve immune function in neutrophils (white blood cells) from adult patients with severe infection. Previous work has shown that a poor response to neutrophil stimulation in the laboratory correlates with decreased patient survival. P4 increases the ability of neutrophils to ingest and kill bacteria, a key determinant of a person's ability to fight infection. Unlike antibiotics, P4 enhances the body's own ability to fight infection, representing a new treatment paradigm that could help overcome the increasing problem of antibiotic resistance. Invasive infection and sepsis account for over a quarter of paediatric intensive care deaths, in part due to difficulties in diagnosis and therefore administration of the most appropriate antibiotics. P4 has been shown to enhance neutrophil function against multiple infecting organisms within 45 minutes, therefore can be administered before the infecting microorganism has been identified and help neutrophils to effectively kill bacteria.
The aims of this study are to evaluate how effectively P4 enhances paediatric neutrophil function and how neutrophil function correlates with disease severity using established laboratory protocols, we will characterise the immune profiles of any high or low responders to better understand how P4 improves neutrophil function and which patients may benefit the most from P4 therapy.
We will recruit healthy children admitted to hospital for elective surgery and take a single blood sample to examine how P4 affects healthy neutrophil function, and to provide a baseline against which P4-treated neutrophils from age-matched children with sepsis can be compared.
The study will be conducted at Alder Hey Children’s NHS Foundation Trust, a site renowned for its Paediatric Intensive Care Unit and with extensive experience in carrying out research studies. The study will last up to two years.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0694
Date of REC Opinion
26 Feb 2018
REC opinion
Further Information Favourable Opinion