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A Randomized Comparison of Empiric Or Pre-Emptive Antibiotic Therapy After Hematopoietic Stem Cell Transplantation

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A Randomized Comparison of Empiric Or Pre-Emptive Antibiotic Therapy After Hematopoietic Stem Cell Transplantation Bone Marrow Transplantation (2007) 40, 157–163 & 2007 Nature Publishing Group All rights reserved 0268-3369/07 $30.00 www.nature.com/bmt ORIGINAL ARTICLE A randomized comparison of empiric or pre-emptive antibiotic therapy after hematopoietic stem cell transplantation MA Slavin1, AP Grigg2, AP Schwarer3, J Szer2, A Spencer3, A Sainani2, KA Thursky1 and AW Roberts2 1Victorian Infectious Diseases Service and Clinical Research Centre of Excellence in Infectious Diseases, Royal Melbourne Hospital, Melbourne, Victoria, Australia; 2Department of Clinical Haematology and Bone Marrow Transplant Service, Royal Melbourne Hospital, Melbourne, Victoria, Australia and 3Bone Marrow Transplant Programme, Alfred Hospital, Melbourne, Victoria, Australia We performed a randomized comparison of pre-emptive fever in the neutropenic patient.4 Despite empiric anti- and empiric antibiotic therapy for adult patients under- bacterial therapy, mortality ranging up to 10% is asso- going allogeneic or autologous stem cell transplantation. ciated with fever and neutropenia, particularly in those One hundred and fifty-three patients were randomized to with an expected duration of neutropenia (ANC receive cefepime either pre-emptively on the day that o0.5 Â 109/l) 410 days.5 Inadequate or delayed therapy neutropenia (ANCo1.0 Â 109 cells/l) developed irrespec- of the initial pathogen has been associated with increased tive of the presence of fever, or at onset of fever and mortality6 as has been the presence of underlying comor- neutropenia (empiric). Although there was no difference bidities.5 between the two arms in the proportion of patients Prophylaxis with oral levofloxacin decreased blood- developing fever or in the median number of days of fever, stream infections (BSIs) in one randomized placebo- the time to onset of fever was a mean of 1 day longer in controlled study, although patients were exclusively each patient on the pre-emptive arm (log rank Po0.001). undergoing autologous transplantation, and most were The number of patients with bloodstream infections was receiving therapy for solid tumours rather than leukaemia significantly reduced in those receiving pre-emptive or lymphoma.7 The use of prophylactic oral fluoroquino- therapy (16/75) compared to the empiric arm (31/76) lones remains controversial8–11 and the effects of oral (Po0.01) but this did not translate into an appreciable antibiotics used prophylactically may not equate to clinical benefit as measured by days of hospitalization, intravenous agents.12 We and others have hypothesized time to engraftment, use of additional antimicrobial that pre-emptive intravenous antibiotic therapy, that is, agents or mortality at 30 days. This study does not antibiotics commenced at onset of neutropenia or on day of support the use of pre-emptive intravenous antibiotic transplant (also referred to as prophylactic antibiotics in therapy in adult stem cell transplant recipients. some recent publications), would reduce the incidence of Bone Marrow Transplantation (2007) 40, 157–163; fever and bacterial infection during the acute phase of doi:10.1038/sj.bmt.1705686; published online 30 April 2007 transplantation.2,13,14 However, pre-emptive intravenous Keywords: empiric; pre-emptive; antibiotics; SCT; antibiotic therapy has not been well evaluated in HSCT neutropenia although two non-randomized studies have suggested that patients may benefit from this approach.13,14 The present study was designed to compare the occurrence of fever, bacterial infection, antibiotic usage and outcome of adult patients undergoing either allogeneic Introduction or autologous stem cell transplant in patients randomized to receive either empiric antibiotic therapy, started at onset Fever occurs in 490% of allogeneic hematopoietic stem of fever, or pre-emptive antibiotic therapy, started at onset cell transplant (HSCT)1,2 and 80% of autologous HSCT of significant neutropenia. recipients.3 Empiric antibacterial regimens such as b-lactam or carbapenem monotherapy or a combination of beta- lactam and an aminoglycoside are recommended to treat Patients and methods The study was conducted at two adult bone marrow Correspondence: Dr MA Slavin, Victorian Infectious Diseases Service transplant centres in Melbourne, Australia. All patients and Clinical Research Centre of Excellence in Infectious Diseases, Royal admitted for HSCT were approached for consent to Melbourne Hospital, Grattan St, Parkville, Melbourne, Victoria 3050, participate. Patients previously randomized, receiving Australia. E-mail: [email protected] systemic antibiotics (except for Pneumocystis jirovecii or Received 30 October 2006; revised 5 March 2007; accepted 13 March post-splenectomy prophylaxis) or with documented beta- 2007; published online 30 April 2007 lactam allergy, fever or infection at the time of admission Pre-emptive versus empiric antibiotics after SCT MA Slavin et al 158 for conditioning for HSCT were excluded. Fluoroquino- engraftment. The use of prophylactic antifungal, antiviral lone prophylaxis was not used in either centre during the and growth factor therapy was according to the unit period of this study. Patients were followed prospectively protocols. Briefly, for allogeneic HSCT recipients, flucona- from time of randomization through to discharge. Deaths zole was used as antifungal prophylaxis at a dose of occurring up to 3 months after transplant were recorded. 400 mg/day from the onset of neutropenia to neutrophil Maximum temperature, additional antimicrobials pre- recovery. All patients seropositive for herpes simplex virus scribed and their doses and all positive microbiology or varicella zoster virus received acyclovir 400 mg orally results were recorded daily. Date of engraftment was twice daily or dose 250 mg intravenously three times daily recorded and time to all events was from date of transplant. from onset of neutropenia until hospital discharge. The research and ethics committees of both hospitals approved the protocol. Severity of sepsis A further analysis was performed on the occurrence and Definitions severity of sepsis syndrome in the cohort of patients treated For the purpose of starting either empiric or pre-emptive at Centre 2. Charts were reviewed by an investigator not antibiotic treatment, and to account for rapidly declining involved in the initial study (AS). At the time of fever, neutrophil counts with conditioning, neutropenia was patients were categorized as to the severity of sepsis defined as ANCo1.0 Â 109/l. Time to engraftment was according to the following scale: grade 1 uneventful, grade defined as time from transplant until the neutrophil count 2 intermediate (one or more of temperature 4391C, rigors, exceeded 0.5 Â 109/l. Fever was an oral temperature of heart rate 4120/min, respiratory rate 420/min, new 38.31C on one occasion, or two temperatures of X381C pulmonary infiltrate on chest radiograph, fluid resuscita- separated by at least 1 h, not associated with infusion of tion o500 ml/h required), grade 3 severe (one or more of blood products. Severe sepsis was defined as fever altered mental status, respiratory rate increase from base- accompanied by a reduction of systolic blood pressure to line greater than 10/min, systolic blood pressure o90 mm o100 mm Hg or a 420 mm Hg decrease from baseline or Hg or decrease 440 mm Hg from baseline, pulse oximetry pulse 4120/min. BSI was any organism detected from at o90% on room air, acidosis (pHo7.36), coagulation least one blood culture. Where more than one species was abnormalities (INR41.5, APTT460 s), rise in serum isolated on a single blood culture, this was considered as creatinine 450% above baseline, rise in bilirubin one infection but designated as polymicrobial. When the 470 mmol/l, fluid resuscitation 4500 ml/h required). same organism was isolated on a sample taken within 14 Admission to intensive care unit (ICU) was also recorded. days of the first positive culture, this was counted as one infection. Standard microbiological methods were used for Transplantation protocols culture and identification of bacteria and fungi. Standard prophylaxis for graft-versus-host disease (GVHD) included the use of cyclosporine and short-course Antimicrobial protocols methotrexate.16 Corticosteroids were not used prophylacti- Pre-emptive therapy with cefepime began on the first day cally. Treatment of moderate to severe GVHD consisted of after randomization when the ANC was o1.0 Â 109/l and optimization of cyclosporin levels and commencement of iv decreasing. The empiric therapy with cefepime began when methylprednisolone 1–2 mg/kg/day or an equivalent oral a patient with a neutrophil count o1.0 Â 109/l developed a prednisolone dose. fever. The dose of cefepime was 1 g intravenously 12 hourly, which was increased to 2 g 12 hourly for severe Statistical analysis sepsis as defined above. The addition of gentamicin, Randomization was on a 1:1 ratio to receive either pre- metronidazole and vancomycin was recommended for emptive or empiric therapy in blocks of 4 with the study severe sepsis. The use of vancomycin was also permitted arm randomly allocated within those blocks and concealed for evidence of central line infection, and metronidazole for before randomization. Stratification was for the centre at diarrhoea or clinical suspicion of neutropenic enterocolitis which the transplant was performed (centre 1 or centre 2) defined by unexpected or severe nausea, vomiting, diar- and stem cell source (allogeneic or autologous). The sample rhoea, abdominal pain or ileus. The addition
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