P4 Peptide in Community Acquired Pneumonia (NCT03497962) | Clinical Trial Compass
CompletedNot Applicable
P4 Peptide in Community Acquired Pneumonia
United Kingdom32 participantsStarted 2013-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of bacteria phagocytosed from neutrophils and macrophages stimulated with P4 compared to unstimulated cells.comparing cells stimulated with P4 and unstimulated cells.
Timeframe: 12 hours
Trial details
NCT IDNCT03497962
SponsorLiverpool University Hospitals NHS Foundation Trust