TY - JOUR
T1 - Quinolone treatment for pediatric bacterial meningitis
T2 - A comparative study of trovafloxacin and ceftriaxone with or without vancomycin
AU - Sáez-Llorens, Xavier
AU - McCoig, Cynthia
AU - Feris, Jesús M.
AU - Vargas, Sergio L.
AU - Klugman, Keith P.
AU - Hussey, Gregory D.
AU - Frenck, Robert W.
AU - Falleiros-Carvalho, Luisa H.
AU - Arguedas, Adriano G.
AU - Bradley, John
AU - Arrieta, Antonio C.
AU - Wald, Ellen R.
AU - Pancorbo, Salvador
AU - McCracken, George H.
AU - Azimi, Parvin
AU - Kelley, Robin
AU - LaVia, William V.
AU - Meissner, Cody
AU - Noel, Gary
AU - Overturf, Gary D.
AU - Rathore, Mobeen
AU - Castaño, Elizabeth
AU - Parra, Mercedes Macias
AU - Morayta, Alfredo
AU - Dos Santos, Boaneventura Antonio
AU - Maia, Tania Maria Rohde
AU - Pimentel, Analiria
AU - Chavez, Ana
AU - Gatica, Luis Eduardo
AU - Soza, Guillermo
AU - Tassara, Enzo
AU - Villaroel, Julita
AU - Wu, Elba
AU - Apra, Ernestina
AU - Tregnaghi, Miguel
AU - Venter, Andre
AU - Cooper, Peter A.
AU - Cotton, Mark F.
AU - Madhi, Shabir
AU - Karaszi, Julia
PY - 2002
Y1 - 2002
N2 - 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. Purpose and design. 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.
AB - 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. Purpose and design. 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.
KW - Bacterial meningitis
KW - Children
KW - Trovafloxacin
UR - http://www.scopus.com/inward/record.url?scp=0036141406&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036141406&partnerID=8YFLogxK
U2 - 10.1097/00006454-200201000-00004
DO - 10.1097/00006454-200201000-00004
M3 - Article
C2 - 11791092
AN - SCOPUS:0036141406
SN - 0891-3668
VL - 21
SP - 14
EP - 22
JO - Pediatric Infectious Disease Journal
JF - Pediatric Infectious Disease Journal
IS - 1
ER -