Quinolone treatment for pediatric bacterial meningitis: a comparative study of trovafloxacin and ceftriaxone with or without vancomycin.
BACKGROUND
Trovafloxacin is a new fluoroquinolone that exhibits good penetration into the central nervous system and excellent antimicrobial activity against common meningeal pathogens, including beta-lactam-resistant pneumococci.


OBJECTIVE
A multicenter, randomized clinical trial was conducted in children with bacterial meningitis to compare the safety and efficacy of trovafloxacin with that of ceftriaxone with or without vancomycin therapy.


RESULTS
A total of 311 patients, ages 3 months to 12 years, were enrolled, of whom 203 were fully evaluable, 108 treated with trovafloxacin and 95 with the conventional regimen. Both groups were comparable with regard to baseline characteristics: age; cerebrospinal fluid findings; use of dexamethasone; history of seizures; and etiologic agents. No significant differences between trovafloxacin and the comparator, respectively, were detected in any of the following outcome measures: clinical success at 5 to 7 weeks after treatment (79% vs. 81%); deaths (2% vs. 3%); seizures after enrollment (22% vs. 21%); and severe sequelae (14% vs. 14%). Only 4 of 284 children developed joint abnormalities up to 6 months after treatment, 1 (0.9%) child received trovafloxacin and 3 (3.1%) received the comparator regimen. None of the evaluable patients experienced significant abnormalities of liver function during treatment. One nonevaluable patient who received trovafloxacin for 5 days and ceftriaxone for 11 days was readmitted to the hospital with hepatitis of unknown etiology 1 day after discharge. The episode resolved with liver function tests returning to normal within 2 months.


CONCLUSIONS
We conclude that trovafloxacin is an effective antibiotic for treatment of pediatric bacterial meningitis. These favorable results support further evaluation of fluoroquinolone therapy for children with meningitis or other serious bacterial infections.
Sáez-Llorens
Xavier
X
McCoig
Cynthia
C
Feris
Jesús M
JM
Vargas
Sergio L
SL
Klugman
Keith P
KP
Hussey
Gregory D
GD
Frenck
Robert W
RW
Falleiros-Carvalho
Luisa H
LH
Arguedas
Adriano G
AG
Bradley
John
J
Arrieta
Antonio C
AC
Wald
Ellen R
ER
Pancorbo
Salvador
S
McCracken
George H
GH
Marques
Silvia R
SR
D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002511:Cephalosporins / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008099:Liver / Q000187:drug effects; D008297:Male; D016920:Meningitis, Bacterial / Q000188:drug therapy* / Q000473:pathology; D009287:Naphthyridines / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D012640:Seizures / Q000209:etiology; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D002511:Cephalosporins; D024841:Fluoroquinolones; D009287:Naphthyridines; D002443:Ceftriaxone; C080163:trovafloxacin