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

Impact of C-reactive Protein Micromethod Testing in Primary Care on Antibiotics Delivery in Patients With Upper or Lower Respiratory Tract Infections: a Randomized Pragmatic Intervention Trial

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Diseases
• Intervention / Treatment: Diagnostic test: Quick test

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Franche-Comté
    • Champlitte, Franche-Comté, France, 70600
      • MSPU des 3 provinces

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

These criteria correspond to factors making interpretation of the CRP value difficult:

• Antibiotics taken in the 15 days prior to inclusion
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TROD; The study involves equipping 70 physicians assigned to the experimental group with a TROD (a bedside rapid test)	Diagnostic test: Quick 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
No Intervention: Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
antibiotics prescriptions in other unit of measure	defined daily doses delivered per 1000 patients in both groups (doctors with or whitout TROD)	through study completion, an average of 1 year
Factors influencing the modulation of antibiotic dispensing	factors may be influence the modulation of antibiotic dispensing: age of physician in year (age group or average age); physician gender, qualitative data (number of male gender or number of femal gender); practitioner training supervisor or not, qualitative date "yes" or "not"; physician geographical location, qualitative data (rural or urban); type of exercice, qualitative data (medical center or single exercice); seasonal effect, comparison of various parameters according to the winter or summer period; volume of patients followed by years (number of patients treated by the general practitioner by year); type of patients followed : number of patients with or without long-term illness followed by the GP, age (years) of patients followed by the GP, gender of patients (in number or percentage) followed by the GP	baseline and one year
Evolution of antibiotic dispensing in the daily delivered dose in both GP's groups (doctors with and without TROD)	temporal variability in the daily delivered dose of antibiotics prescriptions 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	number of chest X-rays prescribed in both groups (doctors with and without TROD); number of biological examinations (blood counts, CRP, ferritinemia, firinogen, urine cytobacteriological examination) prescribed in both groups (doctors with and without TROD);	one year

Collaborators and Investigators

• Sponsor: MSPU des 3 Provinces

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Coagulation Tests; Prothrombin Time
• Other Study ID Numbers: 2022-A00747-36

Drug and device information, study documents

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