Pneumonia Clinical Trial
Official title:
Using P4 Peptide to Augment ex Vivo Phagocyte Function in Patients With Severe Community Acquired Pneumonia (CAP)
The investigators' aim is to find out whether immune cells from patients with a severe chest
infection will react ex vivo to a new immunomodulating peptide, P4 as part of augmented
passive immunotherapy
The investigators know that P4 treatment can successfully improve the efficiency of
specialized immune cells responsible for killing bacteria. The investigators also know that
P4 treatment is effective in healthy human volunteers but wish to extend this observation to
patients that have infection, as immune cells may react differently in these patients. If
this study is successful, the investigators hope to be moving closer to a new treatment
against severe bacterial infections.
The investigators plan to recruit patients admitted to the Intensive Care Unit (ICU) and
healthy volunteers, using carefully established inclusion and exclusions criteria with severe
community acquired pneumonia (CAP) and obtain both blood and (if clinically feasible), a
bronchoscopy BAL sample (washing of lung tissue).
The investigators will examine the response to P4 peptide of alveolar macrophages from
bronchoalveolar lavage (BAL) and neutrophils from peripheral blood collected from patients
with severe pneumonia admitted to the ITU.
The investigators expect to show improved phagocytosis, oxidative burst, cellular activation
(flow cytometry, electron microscopy, cytokine production, transcriptomics) and bacterial
killing when P4 is used to stimulate immune cells and this may lead to a novel approach to
the treatment of severe infections.
The investigators will also examine the effect of P4 on alveolar macrophages and neutrophils
from healthy volunteers in order to ensure comparability with previously published results
and extend observations using S.pneumoniae to other causes of severe pneumonia including
E.coli, Salmonellae, M.tuberculosis and Pseudomonas.
Augmented passive immunotherapy (API) is a novel potential treatment strategy to combat
fulminant bacterial infections. It consists of two components
1. a peptide that enhances bacterial uptake and killing by phagocytes.
2. exogenous antibody (provided with intravenous immunoglobulin, a licensed medicinal
product) which optimizes the phagocytosis. Previous studies of API have included
extensive murine studies of acute and chronic bacterial infection with several different
organisms. P4 has also been tested in aged mice and in mucosal administration.
The investigators will recruit patients with severe community acquired pneumonia on ICU and
healthy volunteers using carefully established inclusion and exclusions criteria.
This research seeks to establish proof-of-concept for augmented passive immunotherapy in
patients with severe pneumonia. Patients with mild to moderate pneumonia often respond to
antibiotic therapy but those with severe community-acquired pneumonia who require admission
to Intensive Care have a hospital mortality of 49.4%, despite antibiotics and optimal
supportive care. These patients represent 6% of all admissions to Intensive Care Units in the
UK. Strategies to improve clinical outcome for this group of patients are much needed and the
investigators' research cohort has been selected to represent this group. The immunological
characteristics of patients with overwhelming sepsis are likely to differ from patients with
milder infection. Immune cells taken from patients with milder forms of sepsis may not
respond to in vitro stimulation in the same way as cells taken from severely septic patients
and therefore should not be used to establish proof-of-concept for a therapy intended for
critically ill patients on Intensive Care.
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