Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities… (NCT07425561) | Clinical Trial Compass
CompletedNot Applicable
Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities (RESPIRE)
Italy300 participantsStarted 2022-01-01
Plain-language summary
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase followed by a prospective phase. Patients were enrolled during two consecutive, non-overlapping periods.
The primary objective of the study is to derive a clinical predictive score for multidrug-resistant (MDR) pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
Who can participate
Age range
18 Years – 90 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:
All patients:
* aged ≥18 years
* who underwent respiratory sample collection within 48 hours of hospital admission and had subsequent positive culture results oleading to a confirmed etiological diagnosis of community-acquired pneumonia (CAP)
* Pneumonia was clinically defined by the presence of two or more clinical signs or symptoms (body temperature \<36.0°C or \>38.0°C; respiratory rate \>20 breaths/min; oxygen saturation on room air \<90%; arterial partial pressure of oxygen \<60 mmHg; cough; sputum production; white blood cell count \<4,000/μL or \>10,000/μL; bandemia \>10%), in addition to radiographic evidence of a new parenchymal opacity or cavitation.
* Only patients with positive respiratory culture results were included in the analysis.
During the prospective phase, only patients whose microbiological samples were collected in the Emergency Department were enrolled.
Exclusion Criteria:
* informed consent was not provided
* age was \<18 years or \>90 years
* pregnant
* pneumonia occurred after more than 48 hours from hospital admission (hospital-acquired pneumonia).
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
Clinical score (RESPIRE) derivation
Timeframe: Within 48 hours from Emergency Department presentation / hospital admission.