Pneumonia Clinical Trial
— P4Official title:
Using P4 Peptide to Augment ex Vivo Phagocyte Function in Patients With Severe Community Acquired Pneumonia (CAP)
Verified date | May 2017 |
Source | Royal Liverpool and Broadgreen University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 32 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria for ITU patients: - 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. Exclusion Criteria for ITU patients: - 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. Bronchoscopy Exclusion criteria (ITU patients): - 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. Inclusion/ Exclusion Criteria for healthy volunteers: - Adults (>18y). - Able to give fully informed consent. - Fluent English speaker. - Non-smoking. - Healthy adults without current illness. - Contraindication to bronchoscopy or immunomodulatory medication. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Liverpool University Hospital | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Royal Liverpool and Broadgreen University Hospitals NHS Trust | Aintree University Hospitals NHS Foundation Trust, Liverpool School of Tropical Medicine |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Does P4 peptide augment phagocytic function in patients with severe community aquired pneumonia | 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 |
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