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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07632651
Acronym
ICARE
Enrollment
140
Registered
2026-06-08
Start date
2023-03-14
Completion date
2024-08-14
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Diseases

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.

Interventions

DIAGNOSTIC_TESTQuick 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

Sponsors

MSPU des 3 Provinces
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Antibiotic dispensing ratethrough study completion, an average of 1 yearThis 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

MeasureTime frameDescription
antibiotics prescriptions in other unit of measurethrough study completion, an average of 1 yeardefined daily doses delivered per 1000 patients in both groups (doctors with or whitout TROD)
Factors influencing the modulation of antibiotic dispensingbaseline and one yearfactors 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
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 periodtemporal variability in the daily delivered dose of antibiotics prescriptions in both GP's groups (doctors with and without TROD)
Complementary radiological and biological examinationsone 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);

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026