Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners (VIP)

August 4, 2023 updated by: Centre Hospitalier Intercommunal Creteil

Impact of the Use of C-reactive Protein in a Micro-method on the Prescription of Antibiotics in General Practitioners Consulting in the Office

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

406

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Boulogne, France, 92100
        • 22 rue de Silly
      • Chelles, France, 77500
        • 18 rue Sainte Bathilde
      • Cormeilles-en-Parisis, France, 95240
        • 25 avenue des frères Lumière
      • Meudon La Forêt, France, 92360
        • 8 Rue Saint-Exupéry
      • Montreuil, France, 93100
        • 258 Bis Rue de Paris
      • Paris, France, 75011
        • 61bis Boulevard de Charonne
      • Paris, France, 75012
        • 25 Rue de Fécamp
      • Paris, France, 75015
        • 237 Rue de la Croix Nivert,
      • Paris, France, 75019
        • 1 Rue Colette Magny
      • Paris, France, 75020
        • 391 Rue des Pyrénées
      • Paris, France, 75020
        • 50 Rue de la Justice
      • Paris, France, 75020
        • 72 Boulevard Davout
      • Stains, France, 93240
        • 20 avenue Gorges Sand
      • Vincennes, France, 94300
        • 19 Rue du Midi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Diagnostic test: Care with C-reactive protein assay in micro method
Care with C-reactive protein assay in micro method
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of antibiotic therapy prescribed
Time Frame: 10 days
with and without POCT-CRP
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old
Time Frame: 10 days
with and without POCT-CRP
10 days
Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old
Time Frame: 10 days
with and without POCT-CRP
10 days
Frequency of antibiotic therapy prescribed in patients older than 65 years old
Time Frame: 10 days
with and without POCT-CRP
10 days
Type of antibiotic prescribed
Time Frame: 10 days
10 days
Frequency of complementary exam
Time Frame: 10 days
with and without POCT-CRP
10 days
type of complementary exam
Time Frame: 10 days
with and without POCT-CRP
10 days
Proportion of number of patients referred to emergency
Time Frame: 10 days
with and without POCT-CRP
10 days
Proportion of number of patients with delayed antibiotic therapy
Time Frame: 10 days
with and without POCT-CRP
10 days
number of prescription following the recommended algorythms
Time Frame: 10 days
Adequacy between the proposed decision algorithm according to the C-reactive protein assay and the antibiotic prescription
10 days
Concordance between the prescription proposed by the decision algorithm as a function of the micro-CRP and the prescription realized: kappa coefficient
Time Frame: 10 days
The assessment of the utility of the POCT procedure
10 days
COVID-19 positive patients
Time Frame: 1 day
Number of COVID-19 positive patients by diagnostic method (From October 2020)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Association Clinique Thérapeutique Infantile du val de Marne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIP
  • 2018-A00242-53 (Other Identifier: ID-RCB)
  • AOR17072 (Other Grant/Funding Number: GIRCI IDF)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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