A multinational, preregistered cohort study of β-lactam/β-lactamase inhibitor combinations for treatment of bloodstream infections due to extended-spectrum-β-lactamase-producing enterobacteriaceae

Antimicrobial Agents and Chemotherapy

Volumn 60, Issue 7, 2016, Pages 4159-4169

  Gutiérrez Gutiérrez, Belén ^a   Pérez Galera, Salvador ^a   Salamanca, Elena ^a   De Cueto, Marina ^a   Calbo, Esther ^b   Almirante, Benito ^c   Viale, Pierluigi ^d   Oliver, Antonio ^e   Pintado, Vicente ^f   Gasch, Oriol ^g   Martínez Martínez, Luis ^h   Pitout, Johann ⁱ   Akova, Murat ^j   Peña, Carmen ^k   Molina, José ^a   Hernández, Alicia ^l   Venditti, Mario ^m   Prim, Nuria ⁿ   Origüen, Julia ^o   Bou, German ^p   Tacconelli, Evelina ^q   Tumbarello, Mario ^r   Hamprecht, Axel ^s   Giamarellou, Helen ^t   Almela, Manel ^u   Pérez, Federico ^v   Schwaber, Mitchell J ^w,x   Bermejo, Joaquín ^y   Lowman, Warren ^z   Hsueh, Po Ren ^aa   Mora Rillo, Marta ^ab   Natera, Clara ^ac   Souli, Maria ^ad   Bonomo, Robert A ^v,ae   Carmeli, Yehuda ^w,x   Paterson, D L ^ak   Pascual, Alvaro ^a,ag   Rodríguez Baño, Jesús ^a,ag   Galvez J ^ah   Del Toro, M D ^ah   Retamar, P ^ah   Falcone, M ^ai   Russo, A ^ai   Daikos, G ^aj   Karaiskos, I ^t   Trecarichi, E M ^r   Losito, A R ^r   Garcia Vazquez E ^l   Gomez J ^l   Roilides, E ^al   Iosifidis, E ^al   Doi, Y ^am   Tuon, F F ^an   Navarro, F ⁿ   Mirelis, B ⁿ   San Juan, R ^o   Fernandez Ruiz M ^o   Larrosa, N ^c   Puig, M ^c   Cisneros, J M ^ao   Gonzalez V ^ao   Rucci, Victoria ^y   Ruiz De Gopegui, E ^e   Marinescu, C I ^e   Farinas M C ^h   Cano, M E ^h   Gozalo, M ^h   Pano Pardo J R ^ap   Navarro San Francisco, C ^ap   Gomez Zorrilla S ^k   Tubau, F ^k   Pournaras, S ^aq   Tsakris, A ^aq   Zarkotou, O ^aq   Azap, O K ^ar   Antoniadou, A ^ad   Poulakou, G ^ad   Virmani, D ^as   Torre Cisneros, J ^at   Perez Nadales E ^at   Gracia Ahulfinger, I ^at   Helvaci, O ^j   Sahin, A O ^j   Canton R ^f   Ruiz, P ^f   Bartoletti, M ^d   Giannella, M ^d   Riemenschneider, F ^q   Badia, C ^b   Xercavins, Mariona ^b   Fontanals, D ^au   Jove E ^au   more..

^a Instituto de Biomedicina de Sevilla   (Spain)

^b HOSPITAL MÚTUA DE TERRASSA   (Spain)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d UNIVERSITY OF BOLOGNA   (Italy)

^e HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^f HOSPITAL RAMÓN Y CAJAL   (Spain)

^g Hospital Universitari Parc Taulí   (Spain)

^h HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

ⁱ UNIVERSITY OF CALGARY   (Canada)

^j HACETTEPE UNIVERSITY   (Turkey)

^k HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^l HOSPITAL UNIVERSITARIO VIRGEN DE LA ARRIXACA   (Spain)

^m SAPIENZA UNIVERSITY OF ROME   (Italy)

ⁿ HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^o HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^p HOSPITAL JUAN CANALEJO   (Spain)

^q UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^r CATHOLIC UNIVERSITY   (Italy)

^s UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^t IASO GENERAL HOSPITAL   (Greece)

^u HOSPITAL CLÍNIC   (Spain)

^v LOUIS STOKES CLEVELAND VA MEDICAL CENTER   (United States)

^w TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^x MINISTRY OF HEALTH   (Israel)

^y HOSPITAL ESPAÑOL   (Argentina)

^z University of the Witwatersrand   (South Africa)

^aa NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^ab HOSPITAL UNIVERSITARIO LA PAZ IDIPAZ   (Spain)

^ac UNIVERSITY OF CÓRDOBA   (Spain)

^ad NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^ae CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^af UNIVERSITY OF QUEENSLAND   (Australia)

^ag UNIVERSITY OF SEVILLE   (Spain)

^ah HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^ai Policlinico Umberto I   (Italy)

^aj LAIKO GENERAL HOSPITAL   (Greece)

^ak ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^al Aristotle University of Thessaloniki   (Greece)

^am UNIVERSITY OF PITTSBURGH   (United States)

^an FEDERAL UNIVERSITY OF PARANÁ   (Brazil)

^ao Hospital Universitario Virgen Rocío   (Spain)

^ap HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^aq UNIVERSITY OF ATHENS   (Greece)

^ar BASKENT UNIVERSITY   (Turkey)

^as UNIVERSITY OF CALGARY   (Canada)

^at HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^au Hospital Parc Tauli   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; BETA LACTAM ANTIBIOTIC; BETA LACTAMASE INHIBITOR; CARBAPENEM DERIVATIVE; DORIPENEM; ERTAPENEM; IMIPENEM; MEROPENEM; PIPERACILLIN PLUS TAZOBACTAM; SULTAMICILLIN; ANTIINFECTIVE AGENT; BETA LACTAM; BETA LACTAMASE;

ADULT; AGED; ARTICLE; BLOODSTREAM INFECTION; CARBAPENEMASE PRODUCING ENTEROBACTERIACEAE; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFICACY; EXTENDED SPECTRUM BETA LACTAMASE PRODUCING ENTEROBACTERIACEAE; FEMALE; HUMAN; IN VITRO STUDY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MORTALITY RATE; MULTICENTER STUDY; OBSERVATIONAL METHOD; OUTCOME VARIABLE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; BACTEREMIA; DRUG EFFECTS; ENTEROBACTERIACEAE; ENZYMOLOGY; KAPLAN MEIER METHOD; METABOLISM; MICROBIOLOGY; MIDDLE AGED; MORTALITY; MULTIVARIATE ANALYSIS; ODDS RATIO; PATHOGENICITY;

AGED; ANTI-BACTERIAL AGENTS; BACTEREMIA; BETA-LACTAMASE INHIBITORS; BETA-LACTAMASES; BETA-LACTAMS; CARBAPENEMS; ENTEROBACTERIACEAE; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; ODDS RATIO; RETROSPECTIVE STUDIES;

EID: 84977072761     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00365-16     Document Type: Article

References (32)

1. Paterson DL, Bonomo R. 2005. Extended-spectrum β-lactamase: a clinical update. Clin Microbiol Rev 18:657-686. http://dx.doi.org/10.1128/CMR.18.4.657-686.2005.
2. Pitout JDD, Laupland KB. 2008. Extended-spectrum β-lactamase-producing Enterobacteriaceae: an emerging public-health concern. Lancet Infect Dis 8:159-166. http://dx.doi.org/10.1016/S1473-3099(08)70041-0.
3. Rodríguez-Baño J, Pascual A. 2008. Clinical significance of extended-spectrum β-lactamases. Expert Rev Anti Infect Ther 6:671-683. http://dx.doi.org/10.1586/14787210.6.5.671.
4. Schwaber MJ, Carmeli Y. 2008. Carbapenem-resistant Enterobacteriaceae: a potential threat. JAMA 300:2911-2913. http://dx.doi.org/10.1001/jama.2008.896.
5. Kumarasamy KK, Toleman MA, Walsh TR, Bagaria J, Butt F, Balakrishnan R, Chaudhary U, Doumith M, Giske CG, Irfan S, Krishnan P, Kumar AV, Maharjan S, Mushtaq S, Noorie T, Paterson DL, Pearson A, Perry C, Pike R, Rao B, Ray U, Sarma JB, Sharma M, Sheridan E, Thirunarayan MA, Turton J, Upadhyay S, Warner M, Welfare W, Livermore DM, Woodford N. 2010. Emergence of a new antibiotic resistance mechanism in India, Pakistan, and the UK: a molecular, biological, and epidemiological study. Lancet Infect Dis 10:597-602. http://dx.doi.org/10.1016/S1473-3099(10)70143-2.
6. Chen YH, Hsueh PR, Badal RE, Hawser SP, Hoban DJ, Bouchillon SK, Ni Y, Paterson DL. 2011. Antimicrobial susceptibility profiles of aerobic and facultative Gram-negative bacilli isolated from patients with intra-abdominal infections in the Asia-Pacific region according to currently established susceptibility interpretive criteria. J Infect 62:280-291. http://dx.doi.org/10.1016/j.jinf.2011.02.009.
7. Hawser S, Hoban D, Bouchillon S, Badal R, Carmeli Y, Hawkey P. 2011. Antimicrobial susceptibility of intra-abdominal gram-negative bacilli from Europe: SMART Europe 2008. Eur J Clin Microbiol Infect Dis 30:173-179. http://dx.doi.org/10.1007/s10096-010-1066-0.
8. Hoban DJ, Bouchillon SK, Hawser SP, Badal RE, Labombardi VJ, DiPersio J. 2010. Susceptibility of gram-negative pathogens isolated from patients with complicated intra-abdominal infections in the United States, 2007-2008: results of the Study for Monitoring Antimicrobial Resistance Trends (SMART). Antimicrob Agents Chemother 54:3031-3034. http://dx.doi.org/10.1128/AAC.01808-09.
9. Díaz MA, Hernández-Bello JR, Rodríguez-Baño J, Martínez-Martínez L, Calvo J, Blanco J, Pascual A, Spanish Group for Nosocomial Infections (GEIH). 2010. The diversity of Escherichia coli strains producing extended-spectrum β-lactamases in Spain: second nationwide study. J Clin Microbiol 48:2840-2845. http://dx.doi.org/10.1128/JCM.02147-09.
10. Ruiz de Alegría C, Rodríguez-Baño J, Cano ME, Hernández-Bello JR, Calvo J, Román E, Díaz MA, Pascual A, Martínez-Martínez L, Spanish Group for Nosocomial Infections (GEIH). 2011. Klebsiella pneumoniae strains producing extended-spectrum β-lactamases in Spain: microbiological and clinical features. J Clin Microbiol 49:1134-1136. http://dx.doi.org/10.1128/JCM.02514-10.
11. Rodríguez-Baño J, Navarro MD, Retamar P, Picón E, Pascual A. 2012. β-Lactam/β-lactam inhibitor combinations for the treatment of bacteremia due to extended-spectrum β-lactamase-producing Escherichia coli: a post hoc analysis of prospective cohorts. Clin Infect Dis 54:167-174. http://dx.doi.org/10.1093/cid/cir790.
12. Vardakas KL, Tansarli GS, Rafailidis PI, Falagas ME. 2012. Carbapenems versus alternative antibiotics for the treatment of bacteremia due to Enterobacteriaceae producing extended-spectrum β-lactamases: a systematic review and meta-analysis. J Antimicrob Chemother 67:2793-2803. http://dx.doi.org/10.1093/jac/dks301.
13. Tamma PD, Han JH, Rock C, Harris AD, Lautenbach E, Hsu AJ, Avdic E, Cosgrove SE, Antibacterial Resistance Leadership Group. 2015. Carbapenem therapy is associated with improved survival compared with piperacillin-tazobactam for patients with extended-spectrum β-lactamase bacteremia. Clin Infect Dis 60:1319-1325. http://dx.doi.org/10.1093/cid/civ003.
14. Bettiol E, Rottier WC, Del Toro MD, Harbarth S, Bonten MJ, Rodríguez-Baño J, COM BACTE consortium. 2014. Improved treatment of multidrug-resistant bacterial infections: utility of clinical studies. Future Microbiol 9:757-771. http://dx.doi.org/10.2217/fmb.14.35.
15. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, STROBE Initiative. 2007. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 147:573-537. http://dx.doi.org/10.7326/0003-4819-147-8-200710160-00010.
16. McCabe WR, Jackson GG. 1962. Gram-negative bacteriemia. Etiology and ecology. Arch Intern Med 110:845-855.
17. Hilf M, Yu VL, Sharp J, Zuravleff JJ, Korvick JA, Muder RR. 1989. Antibiotic therapy for Pseudomonas aeruginosa bacteremia: outcome correlations in a prospective study of 200 patients. Am J Med 87:540-546. http://dx.doi.org/10.1016/S0002-9343(89)80611-4.
18. Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G, SCCM/ESICM/ACCP/ATS/SIS. 2003. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definition Conference. Crit Care Med 31:1250-1256. http://dx.doi.org/10.1097/01.CCM.0000050454.01978.3B.
19. Akaike H. 1974. A new look at the statistical model identification. IEEE Trans Automat Contr 19:716-723. http://dx.doi.org/10.1109/TAC.1974.1100705.
20. Shiber S, Yahav D, Avni T, Leibovici L, Paul M. 2015. β-Lactam/β-lactamase inhibitors versus carbapenems for the treatment of sepsis: systematic review and meta-analysis of randomized controlled trials. J Antimicrob Chemother 70:41-47. http://dx.doi.org/10.1093/jac/dku351.
21. López-Cerero L, Picón E, Morillo C, Hernández JR, Docobo F, Pachón J, Rodríguez-Baño J, Pascual A. 2010. Comparative assessment of inoculum effects on the antimicrobial activity of amoxicillin/clavulanate and piperacillin/tazobactam with ESBL-producing and non-producing Escherichia coli isolates. Clin Microbiol Infect 16:132-136. http://dx.doi.org/10.1111/j.1469-0691.2009.02893.x.
22. Rice LB, Carias LL, Shlaes DM. 1994. In vivo efficacies of β-lactam-β-lactamase inhibitor combinations against a TEM-26-producing strain of Klebsiella pneumoniae. Antimicrob Agents Chemother 38:2663-2664. http://dx.doi.org/10.1128/AAC.38.11.2663.
23. Thauvin-Eliopoulos C, Tripodi MF, Moellering RC, Jr, Eliopoulos GM. 1997. Efficacies of piperacillin-tazobactam and cefepime in rats with experimental intra-abdominal abscesses due to an extended-spectrum betalactamase-producing strain of Klebsiella pneumoniae. Antimicrob Agents Chemother 41:1053-1057.
24. Zimhony O, Chmelnitsky I, Bardenstein R, Goland S, Hammer Muntz O, Navon Venezia S, Carmeli Y. 2006. Endocarditis caused by extended-spectrum β-lactamase-producing Klebsiella pneumoniae: emergence of resistance to ciprofloxacin and piperacillin-tazobactam during treatment despite initial susceptibility. Antimicrob Agents Chemother 50:3179-3182. http://dx.doi.org/10.1128/AAC.00218-06.
25. Rodríguez-Baño J, Picón E, Navarro MD, López-Cerero L, Pascual A, ESBL-REIPI Group. 2012. Impact of changes in CLSI and EUCAST breakpoints for susceptibility in bloodstream infections due to extended-spectrum β-lactamase-producing Escherichia coli. Clin Microbiol Infect 18:894-900. http://dx.doi.org/10.1111/j.1469-0691.2011.03673.x.
26. Retamar P, López-Cerero L, Muniain MA, Pascual Á Rodríguez-Baño J, ESBL-REIPI/GEIH Group. 2013. Impact of the MIC of piperacillin-tazobactam on the outcome of patients with bacteremia due to extendedspectrum-β-lactamase-producing Escherichia coli. Antimicrob Agents Chemother 57:3402-3404. http://dx.doi.org/10.1128/AAC.00135-13.
27. Loder E, Groves T, MacAuley D. 2010. Registration of observational studies. The next step towards research transparency. BMJ 340:c950. http://dx.doi.org/10.1136/bmj.c950.
28. Thomas L, Peterson ED. 2012. The value of statistical analysis plans in observational research: defining high-quality research from the start. JAMA 308:773-774. http://dx.doi.org/10.1001/jama.2012.9502.
29. Hawser SP, Badal RE, Bouchillon SK, Hoban DJ, Biedenbach DJ, Cantón R, Paterson DL. 2013. Monitoring the global in vitro activity of ertapenem against Escherichia coli from intra-abdominal infections: SMART 2002-2010. Int J Antimicrob Agents 41:224-228. http://dx.doi.org/10.1016/j.ijantimicag.2012.10.014.
30. Qiao LD, Chen S, Yang Y, Zhang K, Zheng B, Guo HF, Yang B, Niu YJ, Wang Y, Shi BK, Yang WM, Zhao XK, Gao XF, Chen M, Tian Y. 2013. Characteristics of urinary tract infection pathogens and their in vitro susceptibility to antimicrobial agents in China: data from a multicenter study. BMJ Open 3:e004152. http://dx.doi.org/10.1136/bmjopen-2013-004152.
31. Docobo-PérezF, López-Cerero L, López-Rojas R, Egea P, Domínguez-Herrera J, Rodríguez-Baño J, Pascual A, Pachón J. 2013. Inoculum effect on the efficacies of amoxicillin-clavulanate, piperacillin-tazobactam, and imipenem against extended-spectrum β-lactamase (ESBL)-producing and non-ESBL-producing Escherichia coli in an experimental murine sepsis model. Antimicrob Agents Chemother 57:2109-2113. http://dx.doi.org/10.1128/AAC.02190-12.