Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners

NCT ID: NCT03540706

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2023-03-13

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Infection Respiratory Infections in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Care with C-reactive protein assay in micro method

During a visit to the general practitioner for a clinical suspicion of respiratory infection, the doctor will practice a C-reactive protein assay in micro method. He will prescribe antibiotics according to the result of the dosage

Group Type EXPERIMENTAL

Care with C-reactive protein assay in micro method

Intervention Type DIAGNOSTIC_TEST

Care with C-reactive protein assay in micro method

Care without C-reactive protein assay in micro method

Simple management of a patient coming for a suspicion of respiratory infection without dosage of the C-reactive protein in micro method

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Care with C-reactive protein assay in micro method

Care with C-reactive protein assay in micro method

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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22 rue de Silly

Boulogne, , France

Site Status

18 rue Sainte Bathilde

Chelles, , France

Site Status

25 avenue des frères Lumière

Cormeilles-en-Parisis, , France

Site Status

8 Rue Saint-Exupéry

Meudon-la-Forêt, , France

Site Status

258 Bis Rue de Paris

Montreuil, , France

Site Status

61bis Boulevard de Charonne

Paris, , France

Site Status

25 Rue de Fécamp

Paris, , France

Site Status

237 Rue de la Croix Nivert,

Paris, , France

Site Status

1 Rue Colette Magny

Paris, , France

Site Status

391 Rue des Pyrénées

Paris, , France

Site Status

50 Rue de la Justice

Paris, , France

Site Status

72 Boulevard Davout

Paris, , France

Site Status

20 avenue Gorges Sand

Stains, , France

Site Status

19 Rue du Midi

Vincennes, , France

Site Status

Countries

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France

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Cals JW, Hopstaken RM, Butler CC, Hood K, Severens JL, Dinant GJ. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial. BMC Fam Pract. 2007 Mar 29;8:15. doi: 10.1186/1471-2296-8-15.

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Other Identifiers

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2018-A00242-53

Identifier Type: OTHER

Identifier Source: secondary_id

AOR17072

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VIP

Identifier Type: -

Identifier Source: org_study_id

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