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Completed

NCT Number: NCT07632651

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

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.

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Key information

Conditions

Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MSPU des 3 provinces

Champlitte, Franche-Comté, 70600, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Antibiotic dispensing rate

    Time frame: through study completion, an average of 1 year

    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.

Secondary outcomes

  1. antibiotics prescriptions in other unit of measure

    Time frame: through study completion, an average of 1 year

    defined daily doses delivered per 1000 patients in both groups (doctors with or whitout TROD)

  2. Factors influencing the modulation of antibiotic dispensing

    Time frame: baseline and one year

    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

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

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

    temporal variability in the daily delivered dose of antibiotics prescriptions in both GP's groups (doctors with and without TROD)

  4. Complementary radiological and biological examinations

    Time frame: one year

    • 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);

Sponsors and collaborators

Lead sponsor

MSPU des 3 Provinces

Other

Registry information

Official study title

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

Acronym: ICARE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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