CRP and Lung Ultrasound in Respiratory Evaluation (PLURE)

Evaluation of Point-of-Care Ultrasound Along With C-Reactive Protein-Point of Care Tests Impact on Clinical Decision-making and Perceived Usefulness in Routine Healthcare Use in Patients With Lower Respiratory Tract Infection. Correlation Between C-Reactive Protein Concentrations and Lung Ultrasound Findings.

Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.

This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections.

Study Overview

• Status: Not yet recruiting
• Conditions: Ultrasonography; Lower Respiratory Tract Infection; Primary Health Care; C-Reactive Protein
• Intervention / Treatment: Diagnostic test: Lung ultrasound

• Study Type: Observational
• Enrollment (Estimated): 202

Contacts and Locations

• Study Contact: Name: Anna Llinas Vaquer; Phone Number: 692473511; Email: allinas.lleida.ics@gencat.cat
• Study Contact Backup: Name: Delegado de Protección de Datos; Email: dpd@ticsalutsocial.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with lower respiratory tract infections attending Primary Care centres in Lleida.

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Clinical suspicion of LRTI defined as acute illness lasting less than 21 days, with cough as the main symptom, accompanied by at least one other lower respiratory symptom (such as sputum production, dyspnoea, difficult breathing, or chest pain) without any other explanation for the clinical picture.
• Ability to read, understand and willingness to give written consent to participate in the study.

Exclusion Criteria:

• Patients who have been treated with antibiotics during the last 14 days up to inclusion.
• Patients with hemodynamic instability or that need emergency medical care due to the current clinical condition.
• Previous diagnosis of lung or pleural cancer.
• Thoracic surgery within the past 60 days.
• Lung interstitial diseases.
• Patients who refuse to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound patterns	Standardized criteria will be used to differentiate between normal patterns and those that may indicate pathological conditions. The classification of patterns will include, but not be limited to, tissue heterogeneity, presence of masses or fluids, and characteristics of the edges of lesions.	Each evaluation will be carried out during a dedicated ultrasound session, with an approximate duration of 15 minutes per participant.
C-Reactive Protein	This metric assesses the levels of C-Reactive Protein in the blood, an indicator of inflammation in lower respiratory tract infections already used in the Primary Care practice.	CRP levels will be measured at baseline.

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: 23/222-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No