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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

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date October 21, 2019
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
Frequency of antibiotic therapy prescribed [ Time Frame: 10 days ]
with and without POCT-CRP
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
Rates of antibiotic therapy prescribed [ Time Frame: 10 days ]
with and without POCT-CRP
Change History Complete list of historical versions of study NCT03540706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Frequency of antibiotic therapy prescribed in patients older than 65 years old [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Type of antibiotic prescribed [ Time Frame: 10 days ]
  • Frequency of complementary exam [ Time Frame: 10 days ]
    with and without POCT-CRP
  • type of complementary exam [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Proportion of number of patients referred to emergency [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Proportion of number of patients with delayed antibiotic therapy [ Time Frame: 10 days ]
    with and without POCT-CRP
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • Rates of antibiotic therapy prescribed in patients aged from 3 to 17 years old [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Rates of antibiotic therapy prescribed in patients aged from 18 to 64 years old [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Rates of antibiotic therapy prescribed in patients older than 65 years old [ Time Frame: 10 days ]
    with and without POCT-CRP
  • Type of antibiotic prescribed [ Time Frame: 10 days ]
  • rates of complementary exam [ Time Frame: 10 days ]
    with and without POCT-CRP
  • type of complementary exam [ Time Frame: 10 days ]
    with and without POCT-CRP
  • number of patients referred to emergency [ Time Frame: 10 days ]
    with and without POCT-CRP
  • number of patients with delayed antibiotic therapy [ Time Frame: 10 days ]
    with and without POCT-CRP
  • 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
  • number of practitioners who consider POCT-CRP procedure useful [ Time Frame: 10 days ]
    The assessment of the utility of the POCT procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of the Use of mCRP on the Prescription of Antibiotics in General Practitioners
Official Title  ICMJE Impact of the Use of C-reactive Protein in a Micro-method on the Prescription of Antibiotics in General Practitioners Consulting in the Office
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Respiratory Infection
  • Respiratory Infections in Children
Intervention  ICMJE Diagnostic Test: Care with C-reactive protein assay in micro method
Care with C-reactive protein assay in micro method
Study Arms  ICMJE
  • 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
    Intervention: Diagnostic Test: 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2019)
406
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
3340
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert TOUITOU, MD 01 43 45 47 41 ext +33 robtouitou@gmail.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03540706
Other Study ID Numbers  ICMJE VIP
2018-A00242-53 ( Other Identifier: ID-RCB )
AOR17072 ( Other Grant/Funding Number: GIRCI IDF )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Intercommunal Creteil
Study Sponsor  ICMJE Centre Hospitalier Intercommunal Creteil
Collaborators  ICMJE ACTIV
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP