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Completed

NCT Number: NCT03540706

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

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.

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Key information

Conditions

Respiratory Infection Infections Respiratory Infections in Children Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

22 rue de Silly, Boulogne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Care with C-reactive protein assay in micro method

Diagnostic Test

Care with C-reactive protein assay in micro method

Primary outcomes

  1. Frequency of antibiotic therapy prescribed

    Time frame: 10 days

    with and without POCT-CRP

Secondary outcomes

  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

  11. COVID-19 positive patients

    Time frame: 1 day

    Number of COVID-19 positive patients by diagnostic method (From October 2020)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

  • Association Clinique Thérapeutique Infantile du val de Marne

Registry information

Official study 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

Acronym: VIP

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 30, 2018
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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