Impact of C-reactive Protein Micromethod Testing in Primary Care on Antibiotics Delivery in Patients With Upper or Lower Respiratory Tract Infections

NCT07632651 | Completed

• 1 other identifier: 2022-A00747-36
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The project is a pragmatic approach to primary care. The main objective is to evaluate the impact of making a CRP measurement device available in primary care general practices on antibiotic prescribing for upper respiratory tract (URT) or lower respiratory tract (LRT) infections.

Conditions

Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Antibiotic dispensing rate

  This calculated index is defined by the French health insurance scheme as the "number of antibiotic treatments per 100 patients aged 16 to 65 / attending physician". It is expressed as a percentage.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• antibiotics prescriptions in other unit of measure

  through study completion, an average of 1 year

• Factors influencing the modulation of antibiotic dispensing

  baseline and one year

• Evolution of antibiotic dispensing in the daily delivered dose in both GP's groups (doctors with and without TROD)

  baseline and 3 months, baseline and 6 months, baseline and 1 year, between winter and summer period

• Complementary radiological and biological examinations

  one year

Study Arms (2)

TROD

EXPERIMENTAL

The study involves equipping 70 physicians assigned to the experimental group with a TROD (a bedside rapid test)

Diagnostic Test: Quick test

Control

NO INTERVENTION

The intervention group consists of 70 physicians equipped with a TROD (a bedside rapid test), while the control group comprises 70 physicians without access to a TROD

Interventions

Quick test DIAGNOSTIC_TEST

The 70 GPs in the intervention arm will be able to measure CRP levels by using the Quick read GO in patients with upper or lower respiratory tract infections

TROD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have received information and given written consent
• Patients of any age consulting a general practice with one or more of the following symptoms: fever, cough, arthralgias, myalgias, rhinorrhea;
• Symptomatology evolving for more than 24 hours;
• Symptoms associated with an upper respiratory tract infection such as otitis, angina, laryngitis, rhinopharyngitis, sinusitis; and/or a lower respiratory tract infection such as acute bronchitis, pneumonia, exacerbation of COPD (chronic obstructive pulmonary disease).

You may not qualify if:

• These criteria correspond to factors making interpretation of the CRP value difficult:
• Presence of one of the following signs of severity requiring immediate hospitalization:
• Impairment of higher functions (altered consciousness) Sign of severity (Pas\<90mmHg; HR\>120/min; FR\>30 cycles/min) Temperature \<35 or \>40°c Inhalation pneumonitis
• Sepsis: organ dysfunction, FR\>22cycles/min, PAS≤100 mmHg and Galsgow score ≤ 13(34)
• Immediate hospitalization
• Pregnancy
• Burns
• Heat stroke
• Presenting with an associated serious pathology:
• Associated neoplastic disease in progress
• Severe liver failure
• Ischemic or thromboembolic pathology
• Traumatic pathology
• Inflammatory rheumatism
• Autoimmune disease

Sponsors & Collaborators

• MSPU des 3 Provinces: lead

Study Sites (1)

MSPU des 3 provinces

Champlitte, Franche-Comté, 70600, France

Location

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

Prothrombin Time

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 8, 2026
• Study Start: March 14, 2023
• Primary Completion: March 14, 2024
• Study Completion: August 14, 2024
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

FR (1)