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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 (ICARE)

2. juni 2026 opdateret af: MSPU des 3 Provinces

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TROD
The study involves equipping 70 physicians assigned to the experimental group with a TROD (a bedside rapid test)
Diagnostisk 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
Ingen indgriben: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antibiotic dispensing rate
Tidsramme: 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.
through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
antibiotics prescriptions in other unit of measure
Tidsramme: through study completion, an average of 1 year
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
Tidsramme: 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
baseline and one year
Evolution of antibiotic dispensing in the daily delivered dose in both GP's groups (doctors with and without TROD)
Tidsramme: 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)
baseline and 3 months, baseline and 6 months, baseline and 1 year, between winter and summer period
Complementary radiological and biological examinations
Tidsramme: 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);
one year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

MSPU des 3 Provinces

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. marts 2023

Primær færdiggørelse (Faktiske)

14. marts 2024

Studieafslutning (Faktiske)

14. august 2024

Datoer for studieregistrering

Først indsendt

28. april 2025

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2022-A00747-36

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