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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 13, 2023

Interventions

  • Diagnostic Test: Care with C-reactive protein assay in micro method
    • Care with C-reactive protein assay in micro method

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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
  • COVID-19 positive patients
    • Time Frame: 1 day
    • Number of COVID-19 positive patients by diagnostic method (From October 2020)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Intercommunal Creteil
  • Collaborator
    • Association Clinique Thérapeutique Infantile du val de Marne
  • Provider of Information About this Clinical Study
    • Sponsor

References

Gulliford MC, Moore MV, Little P, Hay AD, Fox R, Prevost AT, Juszczyk D, Charlton J, Ashworth M. Safety of reduced antibiotic prescribing for self limiting respiratory tract infections in primary care: cohort study using electronic health records. BMJ. 2016 Jul 4;354:i3410. doi: 10.1136/bmj.i3410.

Llor C, Moragas A, Cots JM, Lopez-Valcarcel BG; Happy Audit Study Group. Estimated saving of antibiotics in pharyngitis and lower respiratory tract infections if general practitioners used rapid tests and followed guidelines. Aten Primaria. 2017 Jun-Jul;49(6):319-325. doi: 10.1016/j.aprim.2016.07.002. Epub 2016 Nov 22.

van Vugt SF, Verheij TJ, de Jong PA, Butler CC, Hood K, Coenen S, Goossens H, Little P, Broekhuizen BD; GRACE Project Group. Diagnosing pneumonia in patients with acute cough: clinical judgment compared to chest radiography. Eur Respir J. 2013 Oct;42(4):1076-82. doi: 10.1183/09031936.00111012. Epub 2013 Jan 24.

Huang Y, Chen R, Wu T, Wei X, Guo A. Association between point-of-care CRP testing and antibiotic prescribing in respiratory tract infections: a systematic review and meta-analysis of primary care studies. Br J Gen Pract. 2013 Nov;63(616):e787-94. doi: 10.3399/bjgp13X674477.

Kapasi AJ, Dittrich S, Gonzalez IJ, Rodwell TC. Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review. PLoS One. 2016 Aug 3;11(8):e0160278. doi: 10.1371/journal.pone.0160278. eCollection 2016.

Ivaska L, Niemela J, Leino P, Mertsola J, Peltola V. Accuracy and feasibility of point-of-care white blood cell count and C-reactive protein measurements at the pediatric emergency department. PLoS One. 2015 Jun 2;10(6):e0129920. doi: 10.1371/journal.pone.0129920. eCollection 2015.

Esposito S, Tremolati E, Begliatti E, Bosis S, Gualtieri L, Principi N. Evaluation of a rapid bedside test for the quantitative determination of C-reactive protein. Clin Chem Lab Med. 2005;43(4):438-40. doi: 10.1515/CCLM.2005.077.

Cohen R, Lecuyer A, Wollner C, Deberdt P, Thollot F, Henriquet V, de La Rocque F. [Evaluation of impact of CRP rapid test in management of febrile children in ambulatory pediatric practice]. Arch Pediatr. 2008 Jun;15(6):1126-32. doi: 10.1016/j.arcped.2008.03.007. Epub 2008 May 16. French.

Cohen R, Romain O, Levy C, Perreaux F, Decobert M, Hau I, Lecuyer A, Lesprit E, Maman L, Roullaud S, Cheron G, Bekri A, d'Athis P, Henriquet V, de La Rocque F. [Impact of CRP rapid test in management of febrile children in paediatric emergency units of Ile-de-France]. Arch Pediatr. 2006 Dec;13(12):1566-71. doi: 10.1016/j.arcped.2006.09.003. Epub 2006 Oct 27. French.

Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3. Erratum In: Lancet Glob Health. 2017 Jan;5(1):e39.

Minnaard MC, van de Pol AC, Hopstaken RM, van Delft S, Broekhuizen BD, Verheij TJ, de Wit NJ. C-reactive protein point-of-care testing and associated antibiotic prescribing. Fam Pract. 2016 Aug;33(4):408-13. doi: 10.1093/fampra/cmw039. Epub 2016 May 26.

Verlee L, Verheij TJ, Hopstaken RM, Prins JM, Salome PL, Bindels PJ. [Summary of NHG practice guideline 'Acute cough']. Ned Tijdschr Geneeskd. 2012;156(0):A4188. Dutch.

van Vugt SF, Broekhuizen BD, Lammens C, Zuithoff NP, de Jong PA, Coenen S, Ieven M, Butler CC, Goossens H, Little P, Verheij TJ; GRACE consortium. Use of serum C reactive protein and procalcitonin concentrations in addition to symptoms and signs to predict pneumonia in patients presenting to primary care with acute cough: diagnostic study. BMJ. 2013 Apr 30;346:f2450. doi: 10.1136/bmj.f2450.

Cals JW, Hopstaken RM, Butler CC, Hood K, Severens JL, Dinant GJ. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial. BMC Fam Pract. 2007 Mar 29;8:15. doi: 10.1186/1471-2296-8-15.

Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.

Marrie TJ, Durant H, Yates L. Community-acquired pneumonia requiring hospitalization: 5-year prospective study. Rev Infect Dis. 1989 Jul-Aug;11(4):586-99. doi: 10.1093/clinids/11.4.586.

Prina E, Ranzani OT, Torres A. Community-acquired pneumonia. Lancet. 2015 Sep 12;386(9998):1097-108. doi: 10.1016/S0140-6736(15)60733-4. Epub 2015 Aug 12.

Houck PM, Bratzler DW, Nsa W, Ma A, Bartlett JG. Timing of antibiotic administration and outcomes for Medicare patients hospitalized with community-acquired pneumonia. Arch Intern Med. 2004 Mar 22;164(6):637-44. doi: 10.1001/archinte.164.6.637.

Meehan TP, Fine MJ, Krumholz HM, Scinto JD, Galusha DH, Mockalis JT, Weber GF, Petrillo MK, Houck PM, Fine JM. Quality of care, process, and outcomes in elderly patients with pneumonia. JAMA. 1997 Dec 17;278(23):2080-4.

Colvin JM, Muenzer JT, Jaffe DM, Smason A, Deych E, Shannon WD, Arens MQ, Buller RS, Lee WM, Weinstock EJ, Weinstock GM, Storch GA. Detection of viruses in young children with fever without an apparent source. Pediatrics. 2012 Dec;130(6):e1455-62. doi: 10.1542/peds.2012-1391. Epub 2012 Nov 5.

Hernandez-Bou S, Trenchs V, Vanegas MI, Valls AF, Luaces C. Evaluation of the bedside Quikread go(R) CRP test in the management of febrile infants at the emergency department. Eur J Clin Microbiol Infect Dis. 2017 Jul;36(7):1205-1211. doi: 10.1007/s10096-017-2910-2. Epub 2017 Feb 3.

Llor C, Bjerrum L, Munck A, Cots JM, Hernandez S, Moragas A; HAPPY AUDIT Investigators. Access to point-of-care tests reduces the prescription of antibiotics among antibiotic-requesting subjects with respiratory tract infections. Respir Care. 2014 Dec;59(12):1918-23. doi: 10.4187/respcare.03275.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.