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

Primary Purpose

Respiratory Infection, Respiratory Infections in Children

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Care with C-reactive protein assay in micro method
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Infection focused on measuring Respiratory Infections, C-reactive protein, antibiotic prescription

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Chronic cough (more than 3 weeks)

Sites / Locations

  • 22 rue de Silly
  • 18 rue Sainte Bathilde
  • 25 avenue des frères Lumière
  • 8 Rue Saint-Exupéry
  • 258 Bis Rue de Paris
  • 61bis Boulevard de Charonne
  • 25 Rue de Fécamp
  • 237 Rue de la Croix Nivert,
  • 1 Rue Colette Magny
  • 391 Rue des Pyrénées
  • 50 Rue de la Justice
  • 72 Boulevard Davout
  • 20 avenue Gorges Sand
  • 19 Rue du Midi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Care with C-reactive protein assay in micro method

Care without C-reactive protein assay in micro method

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency of antibiotic therapy prescribed
with and without POCT-CRP

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2018
Last Updated
August 4, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Association Clinique Thérapeutique Infantile du val de Marne
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1. Study Identification

Unique Protocol Identification Number
NCT03540706
Brief Title
Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners
Acronym
VIP
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Association Clinique Thérapeutique Infantile du val de Marne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection, Respiratory Infections in Children
Keywords
Respiratory Infections, C-reactive protein, antibiotic prescription

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care with C-reactive protein assay in micro method
Arm Type
Experimental
Arm Description
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
Arm Title
Care without C-reactive protein assay in micro method
Arm Type
No Intervention
Arm Description
Simple management of a patient coming for a suspicion of respiratory infection without dosage of the C-reactive protein in micro method
Intervention Type
Diagnostic Test
Intervention Name(s)
Care with C-reactive protein assay in micro method
Intervention Description
Care with C-reactive protein assay in micro method
Primary Outcome Measure Information:
Title
Frequency of antibiotic therapy prescribed
Description
with and without POCT-CRP
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old
Description
with and without POCT-CRP
Time Frame
10 days
Title
Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old
Description
with and without POCT-CRP
Time Frame
10 days
Title
Frequency of antibiotic therapy prescribed in patients older than 65 years old
Description
with and without POCT-CRP
Time Frame
10 days
Title
Type of antibiotic prescribed
Time Frame
10 days
Title
Frequency of complementary exam
Description
with and without POCT-CRP
Time Frame
10 days
Title
type of complementary exam
Description
with and without POCT-CRP
Time Frame
10 days
Title
Proportion of number of patients referred to emergency
Description
with and without POCT-CRP
Time Frame
10 days
Title
Proportion of number of patients with delayed antibiotic therapy
Description
with and without POCT-CRP
Time Frame
10 days
Title
number of prescription following the recommended algorythms
Description
Adequacy between the proposed decision algorithm according to the C-reactive protein assay and the antibiotic prescription
Time Frame
10 days
Title
Concordance between the prescription proposed by the decision algorithm as a function of the micro-CRP and the prescription realized: kappa coefficient
Description
The assessment of the utility of the POCT procedure
Time Frame
10 days
Title
COVID-19 positive patients
Description
Number of COVID-19 positive patients by diagnostic method (From October 2020)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
22 rue de Silly
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
18 rue Sainte Bathilde
City
Chelles
ZIP/Postal Code
77500
Country
France
Facility Name
25 avenue des frères Lumière
City
Cormeilles-en-Parisis
ZIP/Postal Code
95240
Country
France
Facility Name
8 Rue Saint-Exupéry
City
Meudon La Forêt
ZIP/Postal Code
92360
Country
France
Facility Name
258 Bis Rue de Paris
City
Montreuil
ZIP/Postal Code
93100
Country
France
Facility Name
61bis Boulevard de Charonne
City
Paris
ZIP/Postal Code
75011
Country
France
Facility Name
25 Rue de Fécamp
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
237 Rue de la Croix Nivert,
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
1 Rue Colette Magny
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
391 Rue des Pyrénées
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
50 Rue de la Justice
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
72 Boulevard Davout
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
20 avenue Gorges Sand
City
Stains
ZIP/Postal Code
93240
Country
France
Facility Name
19 Rue du Midi
City
Vincennes
ZIP/Postal Code
94300
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
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Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners

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