Clinafloxacin monotherapy (CI-960) versus ceftazidime plus amikacin for empirical treatment of febrile neutropenic cancer patients.
OBJECTIVE
To assess the efficacy and safety of clinafloxacin as a single agent for the empirical treatment of febrile episodes and bacterial infections in neutropenic cancer patients.


METHODS
An open label, active-controlled, randomized, parallel treatment, multicenter study was conducted where clinafloxacin monotherapy was compared to the combination of ceftazidime plus amikacin (plus optional vancomycin or teicoplanin). Four hundred and nineteen patients were randomized to receive either intravenous clinafloxacin 200 mg every 12 h or intravenous ceftazidime (2 g) iv every 8 h plus intravenous amikacin (15 mg/kg) per day in divided doses. All randomized patients were to receive a minimum of 48 h of primary study drug treatment, after which the primary treatment could be modified. Clinical and microbiological responses were evaluated at 7-21 days post-treatment after study treatment and long term (maximum 28 days), in intent-to-treat and modified intent-to-treat populations.


RESULTS
Clinafloxacin and ceftazidime-amikacin were statistically equivalent for the 72-h defervescence rate, overall defervescence rate, time to defervescence, clinical success rate, by-pathogen microbiological eradication rate, and survival rate. Clinical cure was achieved in 84% (59/70) of patients who received clinafloxacin monotherapy. There were no significant differences between treatments in rates of adverse events or treatment discontinuation rates due to adverse events.


CONCLUSIONS
Clinafloxacin appears to be an appropriate agent for empirical treatment in febrile neutropenic cancer patients.
Glauser
M P
MP
CHUV-Center Hospitalier Universitaire Vaudois, Département de Médecine Interne, Division des Maladies Infectieuses, CHUV, Lausanne, Switzerland.
Brennscheidt
U
U
Cornely
O
O
Grigg
A
A
Figuera
A
A
Keyserling
C
C
Trostmann
U
U
Welling
L
L
Tack
K
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D000583:Amikacin / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000209:etiology; D002442:Ceftazidime / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005334:Fever / Q000188:drug therapy / Q000209:etiology; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D017334:Teicoplanin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014640:Vancomycin / Q000009:adverse effects / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D002511:Cephalosporins; D024841:Fluoroquinolones; D017334:Teicoplanin; D014640:Vancomycin; D000583:Amikacin; C057477:clinafloxacin; D002442:Ceftazidime