Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV.
OBJECTIVE
This double-blind, multicenter trial compared the efficacy and safety of a single daily oral dose of moxifloxacin with oral combination therapy in low-risk febrile neutropenic patients with cancer.


METHODS
Inclusion criteria were cancer, febrile neutropenia, low risk of complications as predicted by a Multinational Association for Supportive Care in Cancer (MASCC) score > 20, ability to swallow, and ≤ one single intravenous dose of empiric antibiotic therapy before study drug treatment initiation. Early discharge was encouraged when a set of predefined criteria was met. Patients received either moxifloxacin (400 mg once daily) monotherapy or oral ciprofloxacin (750 mg twice daily) plus amoxicillin/clavulanic acid (1,000 mg twice daily). The trial was designed to show equivalence of the two drug regimens in terms of therapy success, defined as defervescence and improvement in clinical status during study drug treatment (< 10% difference).


RESULTS
Among the 333 patients evaluated in an intention-to-treat analysis, therapy success was observed in 80% of the patients administered moxifloxacin and in 82% of the patients administered combination therapy (95% CI for the difference, -10% to 8%, consistent with equivalence). Minor differences in tolerability, safety, and reasons for failure were observed. More than 50% of the patients in the two arms were discharged on protocol therapy, with 5% readmissions among those in either arm. Survival was similar (99%) in both arms.


CONCLUSIONS
Monotherapy with once daily oral moxifloxacin is efficacious and safe in low-risk febrile neutropenic patients identified with the help of the MASCC scoring system, discharged early, and observed as outpatients.
Universitätsklinikum Freiburg, Freiburg, Germany. kern@if-freiburg.de
Winfried V
WV
Kern
Oscar
O
Marchetti
Lubos
L
Drgona
Hamdi
H
Akan
Mickel
M
Aoun
Murat
M
Akova
Robrecht
R
de Bock
Marianne
M
Paesmans
Claudio
C
Viscoli
Thierry
T
Calandra
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D019818:Clavulanic Acid / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005334:Fever / Q000188:drug therapy*; D024841:Fluoroquinolones; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D009369:Neoplasms / Q000150:complications*; D009503:Neutropenia / Q000150:complications*; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D012307:Risk Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D001372:Aza Compounds; D004338:Drug Combinations; D024841:Fluoroquinolones; D011804:Quinolines; D019818:Clavulanic Acid; D002939:Ciprofloxacin; D000658:Amoxicillin; D000077266:Moxifloxacin