CClinicalTrials.gg
CompletedNCT03540706VIPUpdated Aug 7, 2023

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

An interventional study of Care with C-reactive protein assay in micro method in Respiratory Infection and Respiratory Infections in Children, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 14 sites in France. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
406
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Respiratory Infection
  • Respiratory Infections in Children

Keywords

  • Respiratory Infections
  • C-reactive protein
  • antibiotic prescription
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 406 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
406 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Diagnostic testCare with C-reactive protein assay in micro method

    Care with C-reactive protein assay in micro method

06

What researchers measure

Primary outcomes

  1. Frequency of antibiotic therapy prescribed

    with and without POCT-CRP

    Time frame: 10 days

Secondary outcomes

  1. Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old

    with and without POCT-CRP

    Time frame: 10 days

  2. Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old

    with and without POCT-CRP

    Time frame: 10 days

  3. Frequency of antibiotic therapy prescribed in patients older than 65 years old

    with and without POCT-CRP

    Time frame: 10 days

  4. Type of antibiotic prescribed

    Time frame: 10 days

  5. Frequency of complementary exam

    with and without POCT-CRP

    Time frame: 10 days

  6. type of complementary exam

    with and without POCT-CRP

    Time frame: 10 days

  7. Proportion of number of patients referred to emergency

    with and without POCT-CRP

    Time frame: 10 days

  8. Proportion of number of patients with delayed antibiotic therapy

    with and without POCT-CRP

    Time frame: 10 days

  9. number of prescription following the recommended algorythms

    Adequacy between the proposed decision algorithm according to the C-reactive protein assay and the antibiotic prescription

    Time frame: 10 days

  10. 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

    Time frame: 10 days

  11. COVID-19 positive patients

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

    Time frame: 1 day

07

Study locations

14 sites
  • 22 rue de Silly
    Boulogne, 92100, France
  • 18 rue Sainte Bathilde
    Chelles, 77500, France
  • 25 avenue des frères Lumière
    Cormeilles-en-Parisis, 95240, France
  • 8 Rue Saint-Exupéry
    Meudon La Forêt, 92360, France
  • 258 Bis Rue de Paris
    Montreuil, 93100, France
  • 61bis Boulevard de Charonne
    Paris, 75011, France
  • 25 Rue de Fécamp
    Paris, 75012, France
  • 237 Rue de la Croix Nivert,
    Paris, 75015, France
  • 1 Rue Colette Magny
    Paris, 75019, France
  • 391 Rue des Pyrénées
    Paris, 75020, France
  • 50 Rue de la Justice
    Paris, 75020, France
  • 72 Boulevard Davout
    Paris, 75020, France
  • 20 avenue Gorges Sand
    Stains, 93240, France
  • 19 Rue du Midi
    Vincennes, 94300, France
08

References and documents

Publications

  • 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. PubMed 27378578 ↗
  • 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. PubMed 27884552 ↗
  • 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. PubMed 23349450 ↗
  • 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. PubMed 24267862 ↗
  • 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. PubMed 27486746 ↗
  • 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. PubMed 26034987 ↗
  • 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. PubMed 15899661 ↗
  • 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. PubMed 18486458 ↗
  • 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. PubMed 17070024 ↗
  • 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. doi: 10.1016/S2214-109X(16)30340-0. PubMed 27495137 ↗
  • 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. PubMed 27230745 ↗
  • 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. PubMed 22917039 ↗
  • 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. PubMed 23633005 ↗
  • 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. PubMed 17394651 ↗
  • 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. PubMed 23915885 ↗
  • 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. PubMed 2772465 ↗
  • 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. PubMed 26277247 ↗
  • 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. PubMed 15037492 ↗
  • 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. PubMed 9403422 ↗
  • 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. PubMed 23129086 ↗
  • 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. PubMed 28160147 ↗
  • 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. PubMed 25468986 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03540706
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Association Clinique Thérapeutique Infantile du val de Marne
Responsible party
Sponsor
First posted
May 30, 2018
Start date
May 1, 2018
Primary completion
Mar 13, 2023
Completion
Mar 13, 2023
Last update
Aug 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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