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

Respiratory Infection Clinical Trial

— VIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540706
• Other study ID #: VIP
• Secondary ID: 2018-A00242-53AO
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 13, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Infection
• Respiratory Infections in Children
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
France	22 rue de Silly	Boulogne
France	18 rue Sainte Bathilde	Chelles
France	25 avenue des frères Lumière	Cormeilles-en-Parisis
France	8 Rue Saint-Exupéry	Meudon La Forêt
France	258 Bis Rue de Paris	Montreuil
France	1 Rue Colette Magny	Paris
France	237 Rue de la Croix Nivert,	Paris
France	25 Rue de Fécamp	Paris
France	391 Rue des Pyrénées	Paris
France	50 Rue de la Justice	Paris
France	61bis Boulevard de Charonne	Paris
France	72 Boulevard Davout	Paris
France	20 avenue Gorges Sand	Stains
France	19 Rue du Midi	Vincennes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Association Clinique Thérapeutique Infantile du val de Marne

Country where clinical trial is conducted

France, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of antibiotic therapy prescribed	with and without POCT-CRP	10 days
Secondary	Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old	with and without POCT-CRP	10 days
Secondary	Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old	with and without POCT-CRP	10 days
Secondary	Frequency of antibiotic therapy prescribed in patients older than 65 years old	with and without POCT-CRP	10 days
Secondary	Type of antibiotic prescribed		10 days
Secondary	Frequency of complementary exam	with and without POCT-CRP	10 days
Secondary	type of complementary exam	with and without POCT-CRP	10 days
Secondary	Proportion of number of patients referred to emergency	with and without POCT-CRP	10 days
Secondary	Proportion of number of patients with delayed antibiotic therapy	with and without POCT-CRP	10 days
Secondary	number of prescription following the recommended algorythms	Adequacy between the proposed decision algorithm according to the C-reactive protein assay and the antibiotic prescription	10 days
Secondary	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	10 days
Secondary	COVID-19 positive patients	Number of COVID-19 positive patients by diagnostic method (From October 2020)	1 day