Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities (RESPIRE)

NCT07425561 | Completed

• 1 other identifier: CEAVC 29707
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia; Pneumonia - Bacterial; Multi Drug Resistant; Multi Drug Resistant Organisms; Emergency; Community Acquired Pneumonia; Community Acquired Pneumonia (CAP); Community Acquired Pneumonia, Severe

Keywords

Pneumonia; Bacterial; Multi Drug Resistant; Emergency Department; CAP; Community acquired pneumonia

Outcome Measures

Primary Outcomes (1)

• Clinical score (RESPIRE) derivation

  The primary objective of the study is to derive a clinical predictive score for MDR pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.

  Within 48 hours from Emergency Department presentation / hospital admission.

Secondary Outcomes (5)

• validation of the derived clinical score in a prospective patient cohort;

  Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.

• comparison of the performance of the developed score in predicting MDR-related pneumonia with validated scores

  Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.

• PPV, NPV, specificity, sensitivity, LR+, LR-, Youden

  Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.

• Calibration

  Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.

• Clinical utiliy

  Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.

Study Arms (3)

MDR Pneumonia Group (Derivation Cohort)

Patients with microbiologically confirmed bacterial pneumonia caused by multidrug-resistant (MDR) pathogens, identified on respiratory culture and antimicrobial susceptibility testing, enrolled during the retrospective phase. MDR was defined as acquired non-susceptibility to at least one agent in three or more antimicrobial categories.

Other: RESPIRE score

Non-MDR Pneumonia Group (Derivation Cohort)

Patients with microbiologically confirmed bacterial pneumonia caused by non-multidrug-resistant pathogens, identified on respiratory culture with available antimicrobial susceptibility testing, enrolled during the retrospective phase. This group served as the comparison cohort for score derivation.

Other: RESPIRE score

Pneumonia Validation Cohort (Prospective)

Consecutive patients presenting to the Emergency Department with a diagnosis of pneumonia who underwent microbiological investigations on respiratory samples during the prospective phase (January 1, 2024-December 31, 2025). This cohort was used to prospectively validate the clinical predictive score derived from the retrospective cohort in a purely observational manner.

Other: RESPIRE score

Interventions

RESPIRE score OTHER

RESPIRE is a clinical risk prediction score developed to estimate the probability of pneumonia caused by multidrug-resistant (MDR) pathogens. In this observational study, the RESPIR-E score is derived and validated using routinely collected clinical and microbiological data. The score is not applied to guide clinical decision-making and does not influence diagnostic or therapeutic management. It is evaluated solely for observational and research purposes.

MDR Pneumonia Group (Derivation Cohort); Non-MDR Pneumonia Group (Derivation Cohort); Pneumonia Validation Cohort (Prospective)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

During the initial retrospective observational phase (2 years), data were collected to establish a retrospective derivation cohort composed of patients with microbiologically confirmed etiological diagnoses of pneumonia. The derivation cohort includes patients who underwent microbiological investigations aimed at identifying the etiological cause of pneumonia within the first 48 hours of presentation to Azienda Ospedaliero Universitaria Careggi. During the second prospective observational phase (2 years), data were collected to establish a prospective cohort of Emergency Department patients, in which the performance of the clinical score derived from the retrospective cohort was evaluated in a purely observational manner.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Careggi University Hospital

Florence, Italy

Location

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial; Emergencies; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 23, 2026
• Study Start: January 1, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 8, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)