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

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ClinicalTrials.gov Identifier: NCT03540706
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
ACTIV
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

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.


Condition or disease Intervention/treatment Phase
Respiratory Infection Respiratory Infections in Children Diagnostic Test: Care with C-reactive protein assay in micro method Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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



Primary Outcome Measures :
  1. Frequency of antibiotic therapy prescribed [ Time Frame: 10 days ]
    with and without POCT-CRP


Secondary Outcome Measures :
  1. Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old [ Time Frame: 10 days ]
    with and without POCT-CRP

  2. Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old [ Time Frame: 10 days ]
    with and without POCT-CRP

  3. Frequency of antibiotic therapy prescribed in patients older than 65 years old [ Time Frame: 10 days ]
    with and without POCT-CRP

  4. Type of antibiotic prescribed [ Time Frame: 10 days ]
  5. Frequency of complementary exam [ Time Frame: 10 days ]
    with and without POCT-CRP

  6. type of complementary exam [ Time Frame: 10 days ]
    with and without POCT-CRP

  7. Proportion of number of patients referred to emergency [ Time Frame: 10 days ]
    with and without POCT-CRP

  8. Proportion of number of patients with delayed antibiotic therapy [ Time Frame: 10 days ]
    with and without POCT-CRP

  9. 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. 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



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Chronic cough (more than 3 weeks)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540706


Contacts
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Contact: Robert TOUITOU, MD 01 43 45 47 41 ext +33 robtouitou@gmail.com

Locations
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France
22 rue de Silly Recruiting
Boulogne, France, 92100
Contact: Marine CHEFDEBIEN         
Principal Investigator: Marine GAISNE-JOLY         
25 avenue des frères Lumière Recruiting
Cormeilles-en-Parisis, France, 95240
Contact: Juliette LION-ALTMAYER         
8 Rue Saint-Exupéry Recruiting
Meudon La Forêt, France, 92360
Contact: EMMANUEL PINTO         
258 Bis Rue de Paris Recruiting
Montreuil, France, 93100
Contact: BLANDINE TRINCARD         
61bis Boulevard de Charonne Recruiting
Paris, France, 75011
Contact: MARION CASADEVALL         
25 Rue de Fécamp Recruiting
Paris, France, 75012
Contact: ANNE LANCELOT         
Principal Investigator: ALICE LAPLANTE         
Principal Investigator: SASKIA MADI-REZGUI         
237 Rue de la Croix Nivert, Recruiting
Paris, France, 75015
Contact: David ZAGHDOUN         
1 Rue Colette Magny Recruiting
Paris, France, 75019
Contact: ISMAEL NURENI-BANAFUNZI         
Principal Investigator: Nastassja LACHINE         
Principal Investigator: Nicole DARDEL         
Principal Investigator: David FAURE         
391 Rue des Pyrénées Recruiting
Paris, France, 75020
Contact: ESTHER BATSCH         
Principal Investigator: MARIE CHEVILLARD         
Principal Investigator: FRANCOIS MYARA         
Principal Investigator: MADY DENANTES         
Principal Investigator: DORA LEVY         
50 Rue de la Justice Recruiting
Paris, France, 75020
Contact: VALERIE JANODY         
72 Boulevard Davout Recruiting
Paris, France, 75020
Contact: YAEL GASMAN         
Principal Investigator: JACQUES YACOUBOVITCH         
20 avenue Gorges Sand Recruiting
Stains, France, 93240
Contact: Richard ROZENFEIN         
19 Rue du Midi Recruiting
Vincennes, France, 94300
Contact: David DJEN         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
ACTIV

Publications:

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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03540706     History of Changes
Other Study ID Numbers: VIP
2018-A00242-53 ( Other Identifier: ID-RCB )
AOR17072 ( Other Grant/Funding Number: GIRCI IDF )
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal Creteil:
Respiratory Infections
C-reactive protein
antibiotic prescription
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents