Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"
NCT ID: NCT04070820
Last Updated: 2020-03-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-09-01
Study Completion Date
2021-03-31
Brief Summary
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Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI).
The aims of our study are:
Primary:
To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care.
Secondary:
1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy.
2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:
A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score".
B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve.
3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI.
4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis.
5. To evaluate the rate of 90-day development of Clostridium difficile infection.
The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form.
All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients.
Period of data collection will be from september 2019 to 31th December 2020.
The aims of our study are:
Primary:
To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care.
Secondary:
1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy.
2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:
A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score".
B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve.
3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI.
4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis.
5. To evaluate the rate of 90-day development of Clostridium difficile infection.
The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form.
All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients.
Period of data collection will be from september 2019 to 31th December 2020.
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Detailed Description
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Conditions
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Enterococcal Bacteraemia
Enterococcus Faecalis Infection
Enterococcal Endocarditis
Bloodstream Infection
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Adult (\>18 years)
* First monomicrobial EF-BSI
* Receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for EF-BSI in empirical or definitive therapy
* Written informed consent
* First monomicrobial EF-BSI
* Receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for EF-BSI in empirical or definitive therapy
* Written informed consent
Exclusion Criteria
* Short term (within 3 days from BSI) mortality
* Other concomitant infection
* Other concomitant infection
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Bologna
OTHER
Sponsor Role
lead
Responsible Party
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Michele Bartoletti
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Michele Bartoletti
Role: PRINCIPAL_INVESTIGATOR
Dipartimento di Scienze mediche e chirurgiche, Alma Mater-University of Bologna
Locations
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Infectious Disease Unit - S.Orsola Malpighi Hospital
Bologna, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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Michele Bartoletti
Role: primary
References
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Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309-17. doi: 10.1086/421946. Epub 2004 Jul 15.
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Rodriguez-Bano J, Lopez-Prieto MD, Portillo MM, Retamar P, Natera C, Nuno E, Herrero M, del Arco A, Munoz A, Tellez F, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Ruiz A, Moya R, Corzo JE, Leon L, Perez-Lopez JA; SAEI/SAMPAC Bacteraemia Group. Epidemiology and clinical features of community-acquired, healthcare-associated and nosocomial bloodstream infections in tertiary-care and community hospitals. Clin Microbiol Infect. 2010 Sep;16(9):1408-13. doi: 10.1111/j.1469-0691.2009.03089.x.
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Cahill TJ, Prendergast BD. Infective endocarditis. Lancet. 2016 Feb 27;387(10021):882-93. doi: 10.1016/S0140-6736(15)00067-7. Epub 2015 Sep 1.
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Reigadas E, Rodriguez-Creixems M, Guembe M, Sanchez-Carrillo C, Martin-Rabadan P, Bouza E. Catheter-related bloodstream infection caused by Enterococcus spp. Clin Microbiol Infect. 2013 May;19(5):457-61. doi: 10.1111/j.1469-0691.2012.03897.x. Epub 2012 May 22.
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BACKGROUND
Chirouze C, Athan E, Alla F, Chu VH, Ralph Corey G, Selton-Suty C, Erpelding ML, Miro JM, Olaison L, Hoen B; International Collaboration on Endocarditis Study Group. Enterococcal endocarditis in the beginning of the 21st century: analysis from the International Collaboration on Endocarditis-Prospective Cohort Study. Clin Microbiol Infect. 2013 Dec;19(12):1140-7. doi: 10.1111/1469-0691.12166. Epub 2013 Mar 20.
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BACKGROUND
McBride SJ, Upton A, Roberts SA. Clinical characteristics and outcomes of patients with vancomycin-susceptible Enterococcus faecalis and Enterococcus faecium bacteraemia--a five-year retrospective review. Eur J Clin Microbiol Infect Dis. 2010 Jan;29(1):107-14. doi: 10.1007/s10096-009-0830-5. Epub 2009 Nov 15.
Reference Type
BACKGROUND
Gray J, Marsh PJ, Stewart D, Pedler SJ. Enterococcal bacteraemia: a prospective study of 125 episodes. J Hosp Infect. 1994 Jul;27(3):179-86. doi: 10.1016/0195-6701(94)90125-2.
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BACKGROUND
Suppli M, Aabenhus R, Harboe ZB, Andersen LP, Tvede M, Jensen JU. Mortality in enterococcal bloodstream infections increases with inappropriate antimicrobial therapy. Clin Microbiol Infect. 2011 Jul;17(7):1078-83. doi: 10.1111/j.1469-0691.2010.03394.x. Epub 2010 Dec 3.
Reference Type
BACKGROUND
Foo H, Chater M, Maley M, van Hal SJ. Glycopeptide use is associated with increased mortality in Enterococcus faecalis bacteraemia--authors' response. J Antimicrob Chemother. 2014 Nov;69(11):3166. doi: 10.1093/jac/dku329. Epub 2014 Aug 12. No abstract available.
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BACKGROUND
Cheah AL, Spelman T, Liew D, Peel T, Howden BP, Spelman D, Grayson ML, Nation RL, Kong DC. Enterococcal bacteraemia: factors influencing mortality, length of stay and costs of hospitalization. Clin Microbiol Infect. 2013 Apr;19(4):E181-9. doi: 10.1111/1469-0691.12132. Epub 2013 Feb 7.
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BACKGROUND
Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
Reference Type
BACKGROUND
Murray BE. The life and times of the Enterococcus. Clin Microbiol Rev. 1990 Jan;3(1):46-65. doi: 10.1128/CMR.3.1.46.
Reference Type
BACKGROUND
Gavalda J, Len O, Miro JM, Munoz P, Montejo M, Alarcon A, de la Torre-Cisneros J, Pena C, Martinez-Lacasa X, Sarria C, Bou G, Aguado JM, Navas E, Romeu J, Marco F, Torres C, Tornos P, Planes A, Falco V, Almirante B, Pahissa A. Brief communication: treatment of Enterococcus faecalis endocarditis with ampicillin plus ceftriaxone. Ann Intern Med. 2007 Apr 17;146(8):574-9. doi: 10.7326/0003-4819-146-8-200704170-00008.
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BACKGROUND
Maki DG, Agger WA. Enterococcal bacteremia: clinical features, the risk of endocarditis, and management. Medicine (Baltimore). 1988 Jul;67(4):248-69.
Reference Type
BACKGROUND
Sandoe JA, Witherden IR, Au-Yeung HK, Kite P, Kerr KG, Wilcox MH. Enterococcal intravascular catheter-related bloodstream infection: management and outcome of 61 consecutive cases. J Antimicrob Chemother. 2002 Oct;50(4):577-82. doi: 10.1093/jac/dkf182.
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BACKGROUND
Ibrahim SL, Zhang L, Brady TM, Hsu AJ, Cosgrove SE, Tamma PD. Low-dose Gentamicin for Uncomplicated Enterococcus faecalis Bacteremia May be Nephrotoxic in Children. Clin Infect Dis. 2015 Oct 1;61(7):1119-24. doi: 10.1093/cid/civ461. Epub 2015 Jun 16.
Reference Type
BACKGROUND
Diallo K, Kern WV, de With K, Luc A, Thilly N, Pulcini C; ESGAP and ESGBIS. Management of bloodstream infections by infection specialists in France and Germany: a cross-sectional survey. Infection. 2018 Jun;46(3):333-339. doi: 10.1007/s15010-018-1122-8. Epub 2018 Feb 3.
Reference Type
BACKGROUND
Diallo K, Thilly N, Luc A, Beraud G, Ergonul O, Giannella M, Kofteridis D, Kostyanev T, Pano-Pardo JR, Retamar P, Kern W, Pulcini C; ESGAP, ESGBIS. Management of bloodstream infections by infection specialists: an international ESCMID cross-sectional survey. Int J Antimicrob Agents. 2018 May;51(5):794-798. doi: 10.1016/j.ijantimicag.2017.12.010. Epub 2018 Jan 5.
Reference Type
BACKGROUND
Bouza E, Kestler M, Beca T, Mariscal G, Rodriguez-Creixems M, Bermejo J, Fernandez-Cruz A, Fernandez-Aviles F, Munoz P; Grupo de Apoyo al Manejo de la Endocarditis. The NOVA score: a proposal to reduce the need for transesophageal echocardiography in patients with enterococcal bacteremia. Clin Infect Dis. 2015 Feb 15;60(4):528-35. doi: 10.1093/cid/ciu872. Epub 2014 Nov 7.
Reference Type
BACKGROUND
Friedman ND, Kaye KS, Stout JE, McGarry SA, Trivette SL, Briggs JP, Lamm W, Clark C, MacFarquhar J, Walton AL, Reller LB, Sexton DJ. Health care--associated bloodstream infections in adults: a reason to change the accepted definition of community-acquired infections. Ann Intern Med. 2002 Nov 19;137(10):791-7. doi: 10.7326/0003-4819-137-10-200211190-00007.
Reference Type
BACKGROUND
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Reference Type
BACKGROUND
Other Identifiers
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EfFAECT
Identifier Type: -
Identifier Source: org_study_id
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