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De‐escalation of antimicrobial treatment for adults with sepsis, severe sepsis or septic shock

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Referencias

References to studies excluded from this review

Bailey 1996 {published data only}

Bailey RR, Begg EJ, Smith AH, Robson RA, Lynn KL, Chambers ST, et al. Prospective, randomized, controlled study comparing two dosing regimens of gentamicin/oral ciprofloxacin switch therapy for acute pyelonephritis. Clinical Nephrology 1996;46(3):183‐6. [PUBMED: 8879853]CENTRAL

Bouadma 2010 {published data only}

Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, et al. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet 2010;375(9713):463‐74. [NCT00472667; PUBMED: 20097417]CENTRAL

Christ‐Crain 2004 {published data only}

Bergmans DC, Bonten MJ, Gaillard CA, van Tiel FH, van der Geest S, de Leeuw PW, et al. Indications for antibiotic use in ICU patients: a one‐year prospective surveillance. Journal of Antimicrobial Chemotherapy 1997;39(4):527‐35. [PUBMED: 9145828]CENTRAL
Christ‐Crain M, Jaccard‐Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, et al. Effect of procalcitonin‐guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster‐randomised, single‐blinded intervention trial. Lancet 2004;363(9409):600‐7. [NCT00407147; PUBMED: 14987884]CENTRAL
Garnacho‐Montero J, Garcia‐Garmendia JL, Barrero‐Almodovar A, Jimenez‐Jimenez FJ, Perez‐Paredes C, Ortiz‐Leyba C. Impact of adequate empirical antibiotic therapy on the outcome of patients admitted to the intensive care unit with sepsis. Critical Care Medicine 2003;31(12):2742‐51. [PUBMED: 14668610]CENTRAL
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Meisner M, Tschaikowsky K, Palmaers T, Schmidt J. Comparison of procalcitonin (PCT) and C‐reactive protein (CRP) plasma concentrations at different SOFA scores during the course of sepsis and MODS. Critical Care 1999;3(1):45‐50. [PUBMED: 11056723]CENTRAL
Rau B, Steinbach G, Gansauge F, Mayer JM, Grunert A, Beger HG. The potential role of procalcitonin and interleukin 8 in the prediction of infected necrosis in acute pancreatitis. Gut 1997;41(6):832‐40. [PUBMED: 9462219 ]CENTRAL
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Horisberger 2004 {published data only}

Horisberger T, Harbarth S, Nadal D, Baenziger O, Fischer JE. G‐CSF and IL‐8 for early diagnosis of sepsis in neonates and critically ill children ‐ safety and cost effectiveness of a new laboratory prediction model: study protocol of a randomized controlled trial [ISRCTN91123847]. Critical Care 2004;8(6):R443‐50. [PUBMED: 15566590]CENTRAL

Jensen 2008 {published data only}

Jensen JU, Hein L, Thornberg K, Loeken J, Tousi H, Larsen KM, et al. Dynamic use of procalcitonin in the intensive care unit. International Journal of Intensive Care 2007;14(2):52‐7. CENTRAL
Jensen JU, Heslet L, Jensen TH, Espersen K, Steffensen P, Tvede M. Procalcitonin increase in early identification of critically ill patients at high risk of mortality. Critical Care Medicine 2006;34(10):2596‐602. [PUBMED: 16915118]CENTRAL
Jensen JU, Lundgren B, Hein L, Mohr T, Petersen PL, Andersen LH, et al. The Procalcitonin And Survival Study (PASS) ‐ a randomised multi‐center investigator‐initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro‐active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients. BMC Infectious Disease 2008;8:91. [NCT00271752; PUBMED: 18620598]CENTRAL
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Jensen JU, Lundgren JD. Procalcitonin in liver transplant patients ‐ yet another stone turned. Critical Care 2008;12(1):108. [PUBMED: 18254924]CENTRAL

Mabasa 2009 {published data only}

Mabasa V, Keenan S, Wiens M, Kangura S. Standard vs adjusted dosing of piperacillin/tazobactam in acute renal failure and septic shock. http://www.controlled‐trials.com/mrct/trial/477949/NCT008167902009. CENTRAL

Masaoka 2000 {published data only}

Masaoka T, Hasegawa H, Takaku F, Mizoguchi H, Asano S, Ikeda Y, et al. The efficacy of intravenous immunoglobulin in combination therapy with antibiotics for severe infections. Japanese Journal of Chemotherapy 2000;48(3):199‐217. [CENTRAL: CN‐00418781]CENTRAL

Roberts 2009 {published data only}

Roberts JA, Roberts MS, Robertson TA, Dalley AJ, Lipman J. Piperacillin penetration into tissue of critically ill patients with sepsis‐‐bolus versus continuous administration?. Critical Care Medicine 2009;37(3):926‐33. [CENTRAL: CN‐00684456]CENTRAL

Schroeder 2009 {published data only}

Hochreiter M, Köhler T, Schweiger AM, Keck FS, Bein B, von Spiegel T, et al. Procalcitonin to guide duration of antibiotic therapy in intensive care patients: a randomized prospective controlled trial. Critical Care 2009;13(3):R83. [PUBMED: 19493352]CENTRAL
Schroeder S, Hochreiter M, Koehler T, Schweiger AM, Bein B, Keck FS, et al. Procalcitonin (PCT)‐guided algorithm reduces length of antibiotic treatment in surgical intensive care patients with severe sepsis: results of a prospective randomized study. Langenbeck's Archives of Surgery / Deutsche Gesellschaft für Chirurgie 2009;394(2):221‐6. [CENTRAL: CN‐00703948]CENTRAL

van den Anker 1995 {published data only}

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Vuori‐Holopainen E, Peltola H, Kallio MJ. Narrow‐ versus broad‐spectrum parenteral anatimicrobials against common infections of childhood: a prospective and randomised comparison between penicillin and cefuroxime. European Journal of Pediatrics 2000;159(12):878‐84. [PUBMED: 11131342]CENTRAL

Leone 2012 {published data only}

De‐escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis. Ongoing studyOctober 2011.

Adukauskiene 2006

Adukauskiene D, Vitkauskiene A. Empiric de‐escalation strategy of antibiotic treatment [Empirinis plataus antimikrobinio veikimo gydymas]. Medicina (Kaunas) 2006;42(9):703‐8. [PUBMED: 17028467]

Alexandraki 2008

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ATS IDSA 2005

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Bagshaw 2009

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Balk 2004

Balk RA. Optimum treatment of severe sepsis and septic shock: Evidence in support of the recommendations. Disease‐a‐Month 2004;50(4):168‐213. [PUBMED: 15133467]

Berild 2006

Berild D, Mohseni A, Diep LM, Jensenius M, Ringertz SH. Adjustment of antibiotic treatment according to the results of blood cultures leads to decreased antibiotic use and costs. Journal of Antimicrobial Chemotherapy 2006;52(2):326‐30. [PUBMED: 16387751]

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Bone RC, Sprung CL, Sibbald WJ. Definitions for sepsis and organ failure. Critical Care Medicine 1992;20(6):724‐6. [PUBMED: 1600757]

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Brunkhorst FM, Reinhart K. Diagnosis and causal treatment of sepsis [Diagnose und kausale Therapie der Sepsis]. Der Internist 2009;50(7):810‐6. [PUBMED: 19506808]

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Carcelero E, Soy D. Antibiotic dose adjustment in the treatment of MRSA infections in patients with acute renal failure undergoing continuous renal replacement therapies. Enfermedades Infecciosas y Microbiología Clínica 2012;30(5):249‐56. [PUBMED: 22130573]

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Cheadle WG. Current perspectives on antibiotic use in the treatment of surgical infections. American Journal of Surgery 1992;164(4A Suppl):44S‐7S. [PUBMED: 1443360]

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Colardyn 2005

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Cordero 2006

Cordero L, Ayers LW. Duration of empiric antibiotics for suspected early‐onset sepsis in extremely low birth weight infants. Infection Control and Hospital Epidemiology 2003;24(9):662‐6. [PUBMED: 14510248]

Cunha 2008

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Erlandsson 2007

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Glowacki 2003

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Gomes Silva 2010

Gomes Silva BN, Andriolo RB, Atallah AN, Salomão R. De‐escalation of antimicrobial treatment for adults with sepsis, severe sepsis or septic shock. Cochrane Database of Systematic Reviews 2010;8(12):CD007934. [PUBMED: 21154391]

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Heenen 2012

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Infectious Diseases Society of America. Bad bugs, no drugs. As antibiotic discovery stagnates . . . a public health crisis brews. http://www.idsociety.org/badbugsnodrugs.html. Alexandria: Infectious Diseases Society of America, 2004.

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Shime N, Satake S, Fujita N. De‐escalation of antimicrobials in the treatment of bacteraemia due to antibiotic‐sensitive pathogens in immunocompetent patients. Infection 2011;39(4):319‐25. [21509424]

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Vallés J, Rello J, Ochagavía A, Garnacho J, Alcalá MA. Community‐acquired bloodstream infection in critically ill adult patients: impact of shock and inappropriate antibiotic therapy on survival. Chest 2003;125(5):1615‐24. [PUBMED: 12740282]

Vincent 2006

Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, et al. Sepsis in European intensive care units: results of the SOAP study. Critical Care Medicine 2006;34(2):344‐53. [PUBMED: 16424713]

Welte 2004

Welte T. Sepsis management ‐‐ antibiotic therapy [Antibiotikatherapie der Sepsis]. Deutsche Medizinische Wochenschrift 2004;129(48):2609‐13. [PUBMED: 15558411]

West 2008

West MA, Moore EE, Shapiro MB, Nathens AB, Cuschieri J, Johnson JL, et al. Inflammation and the host response to injury, a large‐scale collaborative project: patient‐oriented research core‐‐standard operating procedures for clinical care VII‐‐Guidelines for antibiotic administration in severely injured patients. The Journal of Trauma 2008;65(6):1511‐9. [PUBMED: 19077651]

WHO 2002

World Health Organization. Antimicrobial resistance. http://www.who.int/mediacentre/factsheets/fs194/en/index.html.. Geneva, 2002; Vol. Fact sheet:194.

Zaragoza 2008

Zaragoza R, Peman J, Salavert M, Viudes A, Sole A, Jarque I, et al. Multidisciplinary approach to the treatment of invasive fungal infections in adult patients. Prophylaxis, empirical, preemptive or targeted therapy, which is the best in the different hosts?. Therapeutics and Clinical Risk Management 2008;4(6):1261‐80. [PUBMED: 19337433]

References to other published versions of this review

Silva 2010

Silva BNG, Andriolo RB, Atallah ÁN, Salomão R. De‐escalation of antimicrobial treatment for adults with sepsis, severe sepsis or septic shock. Cochrane Database of Systematic Reviews 2010;12:CD007934. [DOI: 10.1002/14651858.CD007934.pub2]

Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Bailey 1996

Intervention not of interest: single large iv dose (10 mg/kg) of gentamicin with a standard multiple dose regimen of gentamicin.

Bouadma 2010

Intervention not of interest, patients were randomized to:

  • group I, to be monitored by an inflammatory marker (procalcitonin), and thus the antibiotics were started or stopped based on predefined cut‐off ranges of procalcitonin concentrations;

  • group II, control group (antibiotics according to present guidelines).

The patients were not randomized to have an initial empirical and broad‐spectrum antimicrobial therapy, adjusted according to the culture results or clinical condition.

Christ‐Crain 2004

Intervention not of interest: patients randomized to be monitored by inflammatory marker (procalcitonin) or control group. The patients were not randomized to have their antimicrobial therapy adjusted according to the culture results or clinical condition.

Clinical condition out of area of interest: ICU patients with no obvious site of Infection.

Horisberger 2004

Interventions not of interest: routine sepsis work up versus intervention strategy with additional cytokine measurements.

Clinical condition not of interest: paediatric patients.

Jensen 2008

Interventions not of interest: procalcitonin measurements.

Clinical condition out of area of interest: ICU patients.

Mabasa 2009

Intervention out of area of interest: participants with septic shock were randomized to have renally adjusted dosage of antibiotics.

Masaoka 2000

Interventions out of area of interest: intravenous immunoglobulin in combination therapy with antibiotics versus antibiotics monotherapy.

Roberts 2009

Intervention out of area of interest: different daily doses of piperacillin‐tazobactam by bolus dosing or continuous infusion.

Schroeder 2009

Intervention out of area of interest, patients were randomized to:

  1. be monitored by inflammatory marker (procalcitonin),

  2. control group (absence of monitoring by inflammatory markers).

van den Anker 1995

Intervention not of interest (once‐daily versus twice‐daily administration of ceftazidime), clinical condition not of interest

(preterm infants).

Vuori‐Holopainen 2000

Interventions out of area of interest: procaine penicillin intramuscularly (narrow‐spectrum antimicrobial) versus cefuroxime intravenously (broad‐spectrum antimicrobial) for 4 to 7 days.

Clinical condition out of area of interest: common infections of childhood.

ICU ‐ intensive care unit

iv ‐ intravenous

Characteristics of ongoing studies [ordered by study ID]

Leone 2012

Trial name or title

De‐escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

Methods

Open label randomized controlled trial

Participants

  • Major subject.

  • Subject having a sepsis engraves (burns) defined according to the following criteria during the initiation of the probability antibiotic treatment:

  • criteria of SIRS [14 ], and

  • a suspected infection, and

  • a failure of organ: low blood pressure, respiratory failure, coma, hepatic insufficiency, renal insufficiency, thrombopenia, spontaneous extension of the TCA.

  • Subject for which an antibiotic treatment was begun within 6 hours following the diagnosis of sepsis engraves (burns).

  • Subject for which taking the microbiological aim was made within 48 hours following the diagnosis of sepsis.

Interventions

1. Experimental: a strategy based on de‐escalation intervention. Procedure: streamlining of the empirical antimicrobial therapy

2. Active comparator: a conservative strategy intervention. Procedure: continuation of the empirical antimicrobial therapy

Outcomes

Starting date

October 2011

Contact information

Marc Leone marc.leone@ap‐hm.fr

Notes

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

A simplified patients' flow for future randomized controlled trials testing the de‐escalation of antimicrobial therapy for septic patients. Adapted with kind permission of David Moher from the figure in Moher 2005.
Figuras y tablas -
Figure 2

A simplified patients' flow for future randomized controlled trials testing the de‐escalation of antimicrobial therapy for septic patients. Adapted with kind permission of David Moher from the figure in Moher 2005.