P4 Peptide in Community Acquired Pneumonia

NCT03497962 | Completed DMC

• 1 other identifier: 12/NW/0730
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Number of bacteria phagocytosed from neutrophils and macrophages stimulated with P4 compared to unstimulated cells.comparing cells stimulated with P4 and unstimulated cells.

  Opsonophagocytic killing assay performed on blood neutrophils and BAL macrophages. Neutrophils and macrophages are stimulated with P4, control is unstilumated neutrophils and macrophages. The comparison is made between the killing of pneumococcal bacteria between the stimulated and unstimulated cells.

  12 hours

Study Arms (2)

ITU patients

25 patients will be recruited from the Intensive Care Unit/ High dependency unit Inclusion- Adults (\>18years) with community acquired pneumonia (CAP).

Procedure: Venepuncture; Procedure: Bronchoscopy

Healthy volunteer

24 healthy adult volunteers will be recruited to establish a comparison data set and to extend the laboratory observations to include other bacterial pathogens.

Procedure: Venepuncture; Procedure: Bronchoscopy

Interventions

Venepuncture PROCEDURE

Taken from established arterial or central lines in critical care setting or by experienced clinicians if no line available and in healthy volunteers.

Healthy volunteer; ITU patients

Bronchoscopy PROCEDURE

Broncho-alveolar lavage to obtain alveolar macrophages

Healthy volunteer; ITU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted into the intensive care unit with community aquired pneumonia (CAP) Healthy volunteer

You may qualify if:

• Adults (\>18y) with community acquired pneumonia.
• Diagnosis of CAP upon hospital admission requires: Radiographic shadowing unexplained by other causes plus Symptoms/signs consistent with acute lower respiratory tract infection.

You may not qualify if:

• Previous hospital admission within 14 days (implies hospital acquired).
• Immunocompromising comorbidity or therapy (e.g. HIV infection, chemotherapy).
• Pregnancy.
• Deemed inappropriate by responsible Intensivist. Already recruited in to an interventional study (where the study therapy may influence the results of this study).
• Failure to obtain consent.
• The patient does not require a bronchoscopy for clinical reasons
• The patient is not invasively ventilated therefore not requiring a bronchoscopy
• The patient condition deteriorates prior to bronchoscopy such that they might no longer tolerate the procedure (e.g. those progressing to require high frequency oscillation, prone-positioning, PEEP\>15cmH2O or FiO2\>0.8 for ventilation).
• Patient does not tolerate bronchoscopy, i.e. if there is oxygen desaturation to \<90% for \>60 seconds or haemodynamic disturbance during the procedure.
• The intensive care clinician responsible for the patient develops any new concerns about the safety of bronchoscopy or bronchoalveolar lavage.
• Adults (\>18y).
• Able to give fully informed consent.
• Fluent English speaker.
• Non-smoking.
• Healthy adults without current illness.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• Liverpool School of Tropical Medicine: collaborator

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood bronchoalveolar lavage (BAL)

MeSH Terms

Conditions

Pneumonia

Interventions

Blood Specimen Collection; Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Respiratory System; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Stephen B Gordon, Professor

  Royal Liverpool University Hospital/ Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: April 13, 2018
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 19, 2025

Record last verified: 2017-05

Locations

GB (1)