A prospective, controlled, randomized, non-blind, comparative study of the efficacy and safety of a once daily high dose of ceftriaxone plus ciprofloxacin versus thrice daily ceftazidime plus amikacin in empirical therapy for febrile neutropenic patients.
BACKGROUND
Empirical antibiotic treatment for febrile neutropenia is well established. The best regimen is still controversial. The purpose of this study was to evaluate the efficacy, safety, and cost of a once daily high dose of ceftriaxone plus ciprofloxacin versus thrice daily ceftazidime plus amikacin in neutropenic febrile patients.


METHODS
Ninety-five patients with febrile neutropenia were included in a prospective, controlled, randomized, non-blind, comparative study. Patients were randomly assigned to one of the treatment groups (63 to the ceftriaxone/ciprofloxacin group and 32 to the ceftazidime/amikacin group) and evaluated as successes or failures according to defined criteria. Daily assessments were made of all patients and all adverse events were recorded.


RESULTS
The overall incidence of documented infections was 45.9%: 24/47 (51.1%) in the ceftriaxone/ciprofloxacin group and 10/27 (37%) in the ceftazidime/amikacin group. There was a significant difference in clinical efficacy between the groups (p=0.011) at the end of therapy. The ceftriaxone/ciprofloxacin group had an overall incidence of resolution and improvement of 95.7% in comparison to 75% in the ceftazidime/amikacin group. Thirty-nine organisms were isolated, 26 (66.67%) gram-negative and 13 (33.33%) gram-positive. There was a low incidence of adverse events in both groups.


CONCLUSIONS
The combination of a single, high dose of ceftriaxone plus ciprofloxacin daily was more effective than the standard combination of thrice daily ceftazidime plus amikacin with no significant adverse events in either group.
Metallidis
Simeon
S
1st Internal Medicine Department, Infectious Diseases Division, AHEPA University Hospital, Thessaloniki, Greece. metallidissimeon@yahoo.gr
Kollaras
Panagiotis
P
Giannakakis
Theodoros
T
Seitanidis
Basilis
B
Kordosis
Theodoros
T
Nikolaidis
John
J
Hatzitolios
Apostolos
A
Nikolaidis
Pavlos
P
D000583:Amikacin / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D001424:Bacterial Infections / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D002442:Ceftazidime / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D002443:Ceftriaxone / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000209:etiology; D006115:Greece; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000150:complications* / Q000209:etiology; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D002939:Ciprofloxacin; D002443:Ceftriaxone; D000583:Amikacin; D002442:Ceftazidime