title: Meropenem versus ceftazidime as empirical monotherapy in febrile neutropenia of paediatric patients with cancer.
abstract: This trial assessed the efficacy and safety of meropenem versus ceftazidime as empirical monotherapy for febrile neutropenia in paediatric cancer patients. In a prospective randomized study, 172 evaluable febrile episodes in the meropenem arm and 170 episodes in the ceftazidime arm were analysed for the clinical and microbiological response dependent on the kind of infection. About half the episodes were classified as fever of unknown origin (FUO) and the remainder as microbiologically or clinically documented infections. The most frequently documented infections in both arms were bacteraemias (22.1 versus 26.5%), predominantly caused by Gram-positive organisms (57.9 versus 71.1%). The success rate of the initial monotherapy differed significantly between the two arms and was 55.8% in the meropenem and 40.0% in the ceftazidime arm (P = 0.003). In addition, a significantly longer duration of fever and of antimicrobial therapy was observed in the ceftazidime arm than in the meropenem arm (median 5 versus 4 days, P = 0.022, and 7 versus 6 days, P = 0.009, respectively). With respect to the kind of infection, differences between the two arms were significant only in episodes classified as FUO but not in documented infections. In both arms, side effects were minimal. Despite the greater response rate for meropenem in FUO, the fact that ceftazidime has been proven to be as effective as meropenem in documented infections in the present study suggests that both drugs are useful as empirical monotherapy in febrile paediatric cancer patients.
authors.affiliation: Department of Paediatric Haematology/Oncology, Children's Medical Hospital, University of Bonn, Adenauerallee 119, D-53113 Bonn, Germany. fleischh@mailer.uni-bonn.de
authors.forename: G
authors.initials: G
authors.lastname: Fleischhack
authors.forename: C
authors.initials: C
authors.lastname: Hartmann
authors.forename: A
authors.initials: A
authors.lastname: Simon
authors.forename: B
authors.initials: B
authors.lastname: Wulff
authors.forename: W
authors.initials: W
authors.lastname: Havers
authors.forename: G
authors.initials: G
authors.lastname: Marklein
authors.forename: C
authors.initials: C
authors.lastname: Hasan
authors.forename: U
authors.initials: U
authors.lastname: Bode
mesh_terms: D001424:Bacterial Infections / Q000188:drug therapy; D002442:Ceftazidime / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004926:Escherichia coli / Q000187:drug effects; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007711:Klebsiella pneumoniae / Q000187:drug effects; D008297:Male; D000077731:Meropenem; D009369:Neoplasms / Q000150:complications* / Q000382:microbiology; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology; D011446:Prospective Studies; D012061:Relapsing Fever / Q000188:drug therapy / Q000209:etiology; D013845:Thienamycins / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002511:Cephalosporins; D013845:Thienamycins; D002442:Ceftazidime; D000077731:Meropenem