CRP and Lung Ultrasound in Respiratory Evaluation

Primary Health Care Clinical Trial

— PLURE  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06294899
• Other study ID #: 23/222-P
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 1, 2028

Study information

• Verified date: April 2024
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: Anna Llinas Vaquer
• Phone: 692473511
• Email: allinas.lleida.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 202
• Est. completion date: September 1, 2028
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Lower Respiratory Tract Infection
• Primary Health Care
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• Lung ultrasound
Lung ultrasound will be performed to patients with suspected lower respiratory tract infections.
• C-Reactive Protein Test
C-Reactive Protein Test will be performed to patients with suspected lower respiratory tract infections.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.