Clinical trial NCT03540706: Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners
Official title: Impact of the Use of C-reactive Protein in a Micro-method on the Prescription of Antibiotics in General Practitioners Consulting in the Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infection
Respiratory Infections in Children
Keywords: Respiratory Infections
C-reactive protein
antibiotic prescription
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
First posted: 2018-05-30
Enrollment: 406
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Respiratory infections, including episodes of coughing with fever, are the main cause of outpatient antibiotic prescription, while a minority of them are linked to bacterial infections requiring antibiotic. These prescriptions are often performed by general practitioners. These unnecessary antibiotic contribute to increased bacterial resistance, side effects and unnecessary costs. Campaigns for the correct prescription of antibiotics have had a real but partial or transient success.

C-reactive protein micro-method (POCT-CRP) could help to differentiate between viral and bacterial infections and thus contribute to the proper use of antibiotics. The decrease in prescription of antibiotics is likely to have an even stronger positive impact in countries like France, where prescription is high.

The objective of this study is to evaluate the use of POCT-CRP in the general practitioner's office in case of suspected respiratory infection.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 3 years
* Clinical suspicion of respiratory infection defined by the presence of at least one respiratory sign among, cough, dyspnea, chest pain and auscultatory abnormality and at least one general sign among fever, sweat, headache, myalgia, impairment of general condition
* Affiliated to a social health insurance
* Signed consent

Exclusion Criteria:

* Duration of symptoms \< 24 hours
* Hospitalization or emergency assessment decision decided from the outset
* Signs of severity before the realization of POCT-CRP
* Patient previously included in the study for the same episode
* Antibiotic therapy within 7 days
* Chronic cough (more than 3 weeks)

Primary outcomes:
measure: Frequency of antibiotic therapy prescribed
timeFrame: 10 days
Secondary outcomes:
measure: Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old
timeFrame: 10 days
measure: Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old
timeFrame: 10 days
measure: Frequency of antibiotic therapy prescribed in patients older than 65 years old
timeFrame: 10 days
measure: Type of antibiotic prescribed
timeFrame: 10 days
measure: Frequency of complementary exam
timeFrame: 10 days
measure: type of complementary exam
timeFrame: 10 days
measure: Proportion of number of patients referred to emergency
timeFrame: 10 days
measure: Proportion of number of patients with delayed antibiotic therapy
timeFrame: 10 days
measure: number of prescription following the recommended algorythms
timeFrame: 10 days
measure: Concordance between the prescription proposed by the decision algorithm as a function of the micro-CRP and the prescription realized: kappa coefficient
timeFrame: 10 days
measure: COVID-19 positive patients
timeFrame: 1 day
Other outcomes:
Locations:
city: Boulogne
country: France
facility: 22 rue de Silly
city: Chelles
country: France
facility: 18 rue Sainte Bathilde
city: Cormeilles-en-Parisis
country: France
facility: 25 avenue des frères Lumière
city: Meudon La Forêt
country: France
facility: 8 Rue Saint-Exupéry
city: Montreuil
country: France
facility: 258 Bis Rue de Paris
city: Paris
country: France
facility: 61bis Boulevard de Charonne
city: Paris
country: France
facility: 25 Rue de Fécamp
city: Paris
country: France
facility: 237 Rue de la Croix Nivert,
city: Paris
country: France
facility: 1 Rue Colette Magny
city: Paris
country: France
facility: 391 Rue des Pyrénées
city: Paris
country: France
facility: 50 Rue de la Justice
city: Paris
country: France
facility: 72 Boulevard Davout
city: Stains
country: France
facility: 20 avenue Gorges Sand
city: Vincennes
country: France
facility: 19 Rue du Midi
Study officials:
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