Selective Reporting of Antibiotic Susceptibility Test Results in Urinary Tract Infections in the Outpatient Setting

NCT03612297 | Unknown

• 1 other identifier: PREPS-17-0026
• Study Type: observational
• Target: 64,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Antibiotic resistance is a serious and increasing worldwide threat to global public health. One of antibiotic stewardship programmes' objectives is to reduce inappropriate broad-spectrum antibiotics' prescription. Selective reporting of antibiotic susceptibility test (AST) results, which consists of reporting to prescribers only few (n=5-6) antibiotics, preferring first-line and narrow-spectrum agents, is one possible strategy advised in recommendations. However, selective reporting of AST has never been evaluated using an experimental design. This study is a pragmatic, prospective, multicentre, controlled (selective reporting vs usual complete reporting of AST), before-after (year 2019 vs 2017) study. Selective reporting of AST is scheduled to be implemented from September 2018 in the ATOUTBIO group of 21 laboratories for all E. coli identified in urine cultures in adult outpatients, and to be compared to the usual complete AST performed in the EVOLAB group of 20 laboratories. The main objective is to assess the impact of selective reporting of AST for E. coli positive urine cultures in the outpatient setting on the prescription of broad-spectrum antibiotics frequently used for urinary tract infections (amoxicillin-clavulanate, third generation cephalosporins and fluoroquinolones). The primary endpoint is the after (2019) - before (2017) difference in prescription rates for the previously mentioned antibiotics/classes that will be compared between the two laboratory groups, using linear regression models. Secondary objectives are to evaluate the feasibility of selective reporting of AST implementation by French laboratories and their acceptability by organising focus groups and individual semi-structured interviews with general practitioners and laboratory professionals.

Conditions

Urinary Tract Infections

Keywords

Antimicrobial resistance; Antimicrobial stewardship; Selective reporting antimicrobial susceptibility tests; Escherichia coli

Outcome Measures

Primary Outcomes (1)

• Impact of selective reporting of AST for E. coli positive urine cultures in outpatient setting on the prescription of broad-spectrum antibiotics frequently used on UTIs (amoxicillin-clavulanate, third generation cephalosporins and fluoroquinolones)

  A comparison of the after (2019) - before (2017) difference of the prescription rates for previous mentioned antibiotics/classes between the two groups, using linear regression models adjusted for variables that differ between groups (laboratory activities, sex-ratio, age).

  2 years (1 year before + 1 year after)

Secondary Outcomes (2)

• Laboratory expenditures (in euros) for the implementation of the intervention

  2 years

• Satisfaction of GPs and laboratory staffs about selective reporting of AST, assessed by a visual analog scale

  1 year

Study Arms (2)

ATOUTBIO

Selective reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults.

Diagnostic Test: Selective reporting of Antibiotic Susceptibility Tests

EVOLAB

Complete reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults.

Interventions

Selective reporting of Antibiotic Susceptibility Tests DIAGNOSTIC_TEST

Selective reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults: results of susceptibility are reported back to the practitioner only for few (n=5-6) antibiotics, those that should be used in first line according to guidelines. Susceptibility results not mentioned in the selective reporting of AST are available at the practitioners' request to the microbiologist. Data used to determine which antibiotic to report for UTIs are the isolated microorganism, the patient age and gender, and antibiotics recommended in national guidelines. As guidelines for UTIs treatment differ by gender, two algorithms have been developed and pilot-tested by three GPs, one microbiologist and two infectious disease physicians.

ATOUTBIO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with E. coli urinary tract infections

You may qualify if:

• adults with an E. coli positive urine culture on which an AST is realised in the year 2017 and 2019 in ATOUTBIO or EVOLAB laboratories
• adults who go to ambulatory care practitioners located in the geographic areas served by all the 41 laboratories studied (in the intervention ATOUTBIO group or the control EVOLAB group).

You may not qualify if:

• None

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator

Related Publications (15)

• Etienne C, Pulcini C. [Prospective cross-sectional study of antibiotic prescriptions in a sample of French general practitioners]. Presse Med. 2015 Mar;44(3):e59-66. doi: 10.1016/j.lpm.2014.07.022. Epub 2015 Jan 31. French.

  PMID: 25650299 BACKGROUND

• Denes E, Prouzergue J, Ducroix-Roubertou S, Aupetit C, Weinbreck P. Antibiotic prescription by general practitioners for urinary tract infections in outpatients. Eur J Clin Microbiol Infect Dis. 2012 Nov;31(11):3079-83. doi: 10.1007/s10096-012-1668-9. Epub 2012 Jun 22.

  PMID: 22722765 BACKGROUND

• Barlam TF, Cosgrove SE, Abbo LM, MacDougall C, Schuetz AN, Septimus EJ, Srinivasan A, Dellit TH, Falck-Ytter YT, Fishman NO, Hamilton CW, Jenkins TC, Lipsett PA, Malani PN, May LS, Moran GJ, Neuhauser MM, Newland JG, Ohl CA, Samore MH, Seo SK, Trivedi KK. Implementing an Antibiotic Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis. 2016 May 15;62(10):e51-77. doi: 10.1093/cid/ciw118. Epub 2016 Apr 13.

  PMID: 27080992 BACKGROUND

• Pulcini C, Tebano G, Mutters NT, Tacconelli E, Cambau E, Kahlmeter G, Jarlier V; EUCIC-ESGAP-EUCAST Selective Reporting Working Group. Selective reporting of antibiotic susceptibility test results in European countries: an ESCMID cross-sectional survey. Int J Antimicrob Agents. 2017 Feb;49(2):162-166. doi: 10.1016/j.ijantimicag.2016.11.014. Epub 2017 Jan 10.

  PMID: 28093208 BACKGROUND

• Coupat C, Pradier C, Degand N, Hofliger P, Pulcini C. Selective reporting of antibiotic susceptibility data improves the appropriateness of intended antibiotic prescriptions in urinary tract infections: a case-vignette randomised study. Eur J Clin Microbiol Infect Dis. 2013 May;32(5):627-36. doi: 10.1007/s10096-012-1786-4. Epub 2012 Dec 8.

  PMID: 23224717 BACKGROUND

• Bourdellon L, Thilly N, Fougnot S, Pulcini C, Henard S. Impact of selective reporting of antibiotic susceptibility test results on the appropriateness of antibiotics chosen by French general practitioners in urinary tract infections: a randomised controlled case-vignette study. Int J Antimicrob Agents. 2017 Aug;50(2):258-262. doi: 10.1016/j.ijantimicag.2017.01.040. Epub 2017 May 31.

  PMID: 28577933 BACKGROUND

• Silveira DP, Artmann E. Accuracy of probabilistic record linkage applied to health databases: systematic review. Rev Saude Publica. 2009 Oct;43(5):875-82. doi: 10.1590/s0034-89102009005000060. Epub 2009 Sep 25. English, Portuguese.

  PMID: 19784456 BACKGROUND

• Langford BJ, Seah J, Chan A, Downing M, Johnstone J, Matukas LM. Antimicrobial Stewardship in the Microbiology Laboratory: Impact of Selective Susceptibility Reporting on Ciprofloxacin Utilization and Susceptibility of Gram-Negative Isolates to Ciprofloxacin in a Hospital Setting. J Clin Microbiol. 2016 Sep;54(9):2343-7. doi: 10.1128/JCM.00950-16. Epub 2016 Jul 6.

  PMID: 27385708 BACKGROUND

• Steffee CH, Morrell RM, Wasilauskas BL. Clinical use of rifampicin during routine reporting of rifampicin susceptibilities: a lesson in selective reporting of antimicrobial susceptibility data. J Antimicrob Chemother. 1997 Oct;40(4):595-8. doi: 10.1093/jac/40.4.595.

  PMID: 9372433 BACKGROUND

• Johnson LS, Patel D, King EA, Maslow JN. Impact of microbiology cascade reporting on antibiotic de-escalation in cefazolin-susceptible Gram-negative bacteremia. Eur J Clin Microbiol Infect Dis. 2016 Jul;35(7):1151-7. doi: 10.1007/s10096-016-2645-5. Epub 2016 Apr 29.

  PMID: 27130036 BACKGROUND

• Tan TY, McNulty C, Charlett A, Nessa N, Kelly C, Beswick T. Laboratory antibiotic susceptibility reporting and antibiotic prescribing in general practice. J Antimicrob Chemother. 2003 Feb;51(2):379-84. doi: 10.1093/jac/dkg032.

  PMID: 12562706 BACKGROUND

• McNulty CA, Lasseter GM, Charlett A, Lovering A, Howell-Jones R, Macgowan A, Thomas M. Does laboratory antibiotic susceptibility reporting influence primary care prescribing in urinary tract infection and other infections? J Antimicrob Chemother. 2011 Jun;66(6):1396-404. doi: 10.1093/jac/dkr088. Epub 2011 Mar 11.

  PMID: 21398297 BACKGROUND

• Sharland M, Pulcini C, Harbarth S, Zeng M, Gandra S, Mathur S, Magrini N; 21st WHO Expert Committee on Selection and Use of Essential Medicines. Classifying antibiotics in the WHO Essential Medicines List for optimal use-be AWaRe. Lancet Infect Dis. 2018 Jan;18(1):18-20. doi: 10.1016/S1473-3099(17)30724-7. Epub 2017 Dec 20. No abstract available.

  PMID: 29303731 BACKGROUND

• Pulcini C, Huttner A. CMI policy on antimicrobial stewardship research. Clin Microbiol Infect. 2018 Feb;24(2):91-92. doi: 10.1016/j.cmi.2017.11.006. Epub 2017 Nov 10. No abstract available.

  PMID: 29133158 BACKGROUND

• Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, Gissot C, Weill A, Fagot-Campagna A. Value of a national administrative database to guide public decisions: From the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017 Oct;65 Suppl 4:S149-S167. doi: 10.1016/j.respe.2017.05.004. Epub 2017 Jul 27.

  PMID: 28756037 BACKGROUND

Related Links

• Santé publique France. Résistance aux anti-infectieux - Données par pathogène. 2017.
• Agence nationale de sécurité du médicament et des produits de santé. L'évolution des consommations d'antibiotiques en France entre 2000 et 2015
• Société de Pathologie Infectieuse de Langue Française. Recommandations pour la prise en charge des infections urinaires bactériennes communautaires de l'adulte. 2017.
• Ministère chargé de la santé. Plan national d'alerte sur les antibiotiques. 2011-2016.
• Ministère des Solidarités et de la Santé. La mise en place d'antibiogrammes ciblés dans les infections urinaires à Escherichia coli. 2016

MeSH Terms

Conditions

Urinary Tract Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Céline Pulcini, Professor

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline Pulcini, Professor

CONTACT

+33 383154097; celine.pulcini@univ-lorraine.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 2, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share