Empirical antimicrobial monotherapy in patients after high-dose chemotherapy and autologous stem cell transplantation: a randomised, multicentre trial.
We report on 232 patients undergoing autologous haematopoietic stem cell transplantation (ASCT) entered into a multicentre, randomised trial comparing the efficacy and tolerability of meropenem (MPM) with that of piperacillin/tazobactam (P/T) as empirical antimicrobial first-line therapy for febrile neutropenia. In 27.6% of patients in the MPM group and 22.4% in the P/T group, therapy was initially supplemented with a glycopeptide for venous catheter infection or bacteraemia because of coagulase-negative staphylococci. Complete response rate after 72 h was 63.8% in the MPM group and 49.6% in the P/T group (P = 0.034). Overall complete response rate after treatment modification was 94.0% in the MPM group and 93.1% in the P/T group. Median time to defervescence was 2 d in the MPM group and 3 d in the P/T group. The most frequently isolated pathogens were Gram-positive cocci. Treatment was well tolerated in both groups. One patient (0.4%) died from infection. Empirical first-line therapy with MPM as well as with P/T is safe and effective in febrile episodes emerging after ASCT. Higher response rates to primary treatment can be achieved with MPM.
Reich
Gernot
G
Department of Haematology, Oncology and Tumour Immunology, Charité University Hospital, Campus Buch, Lindenberger Weg, Berlin, Germany. gmaschmeyer@klinikumevb.de
Cornely
Oliver A
OA
Sandherr
Michael
M
Kubin
Thomas
T
Krause
Stefan
S
Einsele
Hermann
H
Thiel
Eckhard
E
Bellaire
Tanja
T
Dörken
Bernd
B
Maschmeyer
Georg
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D005334:Fever / Q000188:drug therapy / Q000209:etiology / Q000382:microbiology; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D000077731:Meropenem; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D009503:Neutropenia / Q000150:complications* / Q000209:etiology; D009894:Opportunistic Infections / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology; D010397:Penicillanic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D010878:Piperacillin / Q000627:therapeutic use; D011446:Prospective Studies; D000078142:Tazobactam; D013845:Thienamycins / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D013845:Thienamycins; D010397:Penicillanic Acid; D000077731:Meropenem; D000078142:Tazobactam; D010878:Piperacillin