Opportunities for antibiotic optimisation and outcome improvement in patients with negative blood cultures: study protocol for a cluster-randomised crossover trial, the NO-BACT study

Silvia Jiménez-Jorge, Zaira R Palacios-Baena, Clara M Rosso-Fernández, José A Girón-Ortega, Jesús Rodriguez-Baño, Pilar Retamar, Silvia Jiménez-Jorge, Zaira R Palacios-Baena, Clara M Rosso-Fernández, José A Girón-Ortega, Jesús Rodriguez-Baño, Pilar Retamar

Abstract

Introduction: Patients with negative blood cultures (BCx) represent 85%-90% of all patients with BCx taken during hospital admission. This population usually includes a heterogeneous group of patients admitted with infectious diseases or febrile syndromes that require a blood culture. There is very little evidence of the clinical characteristics and antibiotic treatment given to these patients.

Methods and analysis: In a preliminary exploratory prospective cohort study of patients with BCx taken, the clinical/therapeutic characteristics and outcomes/antimicrobial stewardship opportunities of a population of patients with negative BCx will be analysed. In the second phase, using a cluster randomised crossover design, the implementation of an antimicrobial stewardship intervention targeting patients with negative BCx will be evaluated in terms of quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality.

Ethics and dissemination: This study has been and registered with clinicaltrials.gov. The findings of our study may support the implementation in clinical practice of an antimicrobial stewardship intervention to optimise the use of antibiotics in patients with negative BCx. The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number: NCT03535324.

Keywords: antibiotic prescribing; antimicrobial stewardship programs; cluster randomised controlled trial; negative blood culture.

Conflict of interest statement

Competing interests: ZRP-B reports personal fees from Gilead, outside the submitted work. JR-B and PR participated in accredited educational activities supported by Merck through unrestricted grants, outside the submitted work.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Crossover design of the NO-BACT study.
Figure 2
Figure 2
Experimental intervention—NO-BACT.

References

    1. Turner RB, Valcarlos E, Won R, et al. . Impact of infectious diseases consultation on clinical outcomes of patients with Staphylococcus aureus bacteremia in a community health system. Antimicrob Agents Chemother 2016;60:5682–7. 10.1128/AAC.00439-16
    1. Menu E, Gouriet F, Casalta J-P, et al. . Evaluation of empirical treatment for blood culture-negative endocarditis. J. Antimicrob. Chemother. 2017;72:290–8. 10.1093/jac/dkw362
    1. Cercenado Mansilla E, Cantón Moreno R. Diagnóstico microbiológico de la bacteriemia y la fungemia: hemocultivos y métodos moleculares : Procedimientos en Microbiología Clínica, Sociedad Española de Enfermedades Infecciosas Y Microbiología Clínica. 62 SEIMC, 2017. (Accessed 04 February 2019).
    1. Jover F, Cuadrado J-M, Andreu L, et al. . A comparative study of bacteremic and non-bacteremic pneumococcal pneumonia. Eur J Intern Med 2008;19:15–21. 10.1016/j.ejim.2007.03.015
    1. Kim Y, Seo M-R, Kim S-J, et al. . Usefulness of blood cultures and radiologic imaging studies in the management of patients with community-acquired acute pyelonephritis. Infect Chemother 2017;49:22–30. 10.3947/ic.2017.49.1.22
    1. Rodríguez-Baño J, Paño-Pardo JR, Alvarez-Rocha L, et al. . Programs for optimizing the use of antibiotics (proA) in Spanish hospitals: GEIH-SEIMC, SEFH and SEMPSPH consensus document. Enferm Infecc Microbiol Clin 2012;30:22.e1–22.e23.
    1. Tamma PD, Avdic E, Keenan JF, et al. . What is the more effective antibiotic stewardship intervention: Preprescription authorization or Postprescription review with feedback? Clin Infect Dis 2017;64:537–43.
    1. Davey P, Marwick CA, Scott CL, et al. . Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev 2017;39 10.1002/14651858.CD003543.pub4
    1. Campbell MK, Piaggio G, Elbourne DR, et al. . Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661 10.1136/bmj.e5661
    1. Weijer C, Grimshaw JM, Eccles MP, et al. . The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLoS Med 2012;9:e1001346 10.1371/journal.pmed.1001346
    1. Sim J, Dawson A. Informed consent and cluster-randomized trials. Am J Public Health 2012;102:480–5. 10.2105/AJPH.2011.300389
    1. McRae AD, Weijer C, Binik A, et al. . When is informed consent required in cluster randomized trials in health research? Trials 2011;12:202 10.1186/1745-6215-12-202
    1. Magiorakos A-P, Srinivasan A, Carey RB, et al. . Multidrug-Resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clinical Microbiology and Infection 2012;18:268–81. 10.1111/j.1469-0691.2011.03570.x
    1. Evans SR, Rubin D, Follmann D, et al. . Desirability of outcome ranking (door) and response adjusted for duration of antibiotic risk (radar). Clin Infect Dis. 2015;61:800–6. 10.1093/cid/civ495
    1. López-Cortés LE, del Toro MD, Gálvez-Acebal J, et al. . Impact of an evidence-based bundle intervention in the quality-of-care management and outcome of Staphylococcus aureus bacteremia. Clinical Infectious Diseases 2013;57:1225–33. 10.1093/cid/cit499
    1. Schorr C, Odden A, Evans L, et al. . Implementation of a multicenter performance improvement program for early detection and treatment of severe sepsis in general medical-surgical wards. J. Hosp. Med. 2016;11:S32–9. 10.1002/jhm.2656
    1. Turner RM, White IR, Croudace T, et al. . Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med 2007;26:274–89. 10.1002/sim.2537
    1. Sim J. Addressing conflicts in research ethics: consent and risk of harm. Physiother. Res. Int. 2010;15:80–7. 10.1002/pri.483

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit