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

NCT03540706 | Completed

• 3 other identifiers: VIP2018-A00242-53AOR17072
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 14

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.

Conditions

Respiratory Infection; Respiratory Infections in Children

Keywords

Respiratory Infections; C-reactive protein; antibiotic prescription

Outcome Measures

Primary Outcomes (1)

• Frequency of antibiotic therapy prescribed

  with and without POCT-CRP

  10 days

Secondary Outcomes (11)

• Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old

  10 days

• Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old

  10 days

• Frequency of antibiotic therapy prescribed in patients older than 65 years old

  10 days

• Type of antibiotic prescribed

  10 days

• Frequency of complementary exam

  10 days

Study Arms (2)

Care with C-reactive protein assay in micro method

EXPERIMENTAL

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

Diagnostic Test: Care with C-reactive protein assay in micro method

Care without C-reactive protein assay in micro method

NO INTERVENTION

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

Interventions

Care with C-reactive protein assay in micro method DIAGNOSTIC_TEST

Care with C-reactive protein assay in micro method

Care with C-reactive protein assay in micro method

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator

Study Sites (14)

22 rue de Silly

Boulogne, 92100, France

Location

18 rue Sainte Bathilde

Chelles, 77500, France

Location

25 avenue des frères Lumière

Cormeilles-en-Parisis, 95240, France

Location

8 Rue Saint-Exupéry

Meudon-la-Forêt, 92360, France

Location

258 Bis Rue de Paris

Montreuil, 93100, France

Location

61bis Boulevard de Charonne

Paris, 75011, France

Location

25 Rue de Fécamp

Paris, 75012, France

Location

237 Rue de la Croix Nivert,

Paris, 75015, France

Location

1 Rue Colette Magny

Paris, 75019, France

Location

391 Rue des Pyrénées

Paris, 75020, France

Location

50 Rue de la Justice

Paris, 75020, France

Location

72 Boulevard Davout

Paris, 75020, France

Location

20 avenue Gorges Sand

Stains, 93240, France

Location

19 Rue du Midi

Vincennes, 94300, France

Location

Related Publications (22)

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MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: May 1, 2018
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)