Quinolone treatment for pediatric bacterial meningitis: A comparative study of trovafloxacin and ceftriaxone with or without vancomycin

Xavier Sáez-Llorens, Cynthia McCoig, Jesús M. Feris, Sergio L. Vargas, Keith P. Klugman, Gregory D. Hussey, Robert W. Frenck, Luisa H. Falleiros-Carvalho, Adriano G. Arguedas, John Bradley, Antonio C. Arrieta, Ellen R. Wald, Salvador Pancorbo, George H. McCracken, Parvin Azimi, Robin Kelley, William V. LaVia, Cody Meissner, Gary Noel, Gary D. OverturfMobeen Rathore, Elizabeth Castaño, Mercedes Macias Parra, Alfredo Morayta, Boaneventura Antonio Dos Santos, Tania Maria Rohde Maia, Analiria Pimentel, Ana Chavez, Luis Eduardo Gatica, Guillermo Soza, Enzo Tassara, Julita Villaroel, Elba Wu, Ernestina Apra, Miguel Tregnaghi, Andre Venter, Peter A. Cooper, Mark F. Cotton, Shabir Madhi, Julia Karaszi

Research output: Contribution to journalArticle

56 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)14-22
Number of pages9
JournalPediatric Infectious Disease Journal
Volume21
Issue number1
DOIs
StatePublished - 2002

Fingerprint

Bacterial Meningitides
Ceftriaxone
Quinolones
Vancomycin
Pediatrics
Fluoroquinolones
Therapeutics
Seizures
Liver Function Tests
beta-Lactams
Streptococcus pneumoniae
trovafloxacin
Meningitis
Bacterial Infections
Dexamethasone
Hepatitis
Cerebrospinal Fluid
Central Nervous System
Randomized Controlled Trials
Joints

Keywords

  • Bacterial meningitis
  • Children
  • Trovafloxacin

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)

Cite this

Quinolone treatment for pediatric bacterial meningitis : A comparative study of trovafloxacin and ceftriaxone with or without vancomycin. / Sáez-Llorens, Xavier; McCoig, Cynthia; Feris, Jesús M.; Vargas, Sergio L.; Klugman, Keith P.; Hussey, Gregory D.; Frenck, Robert W.; Falleiros-Carvalho, Luisa H.; Arguedas, Adriano G.; Bradley, John; Arrieta, Antonio C.; Wald, Ellen R.; Pancorbo, Salvador; McCracken, George H.; Azimi, Parvin; Kelley, Robin; LaVia, William V.; Meissner, Cody; Noel, Gary; Overturf, Gary D.; Rathore, Mobeen; Castaño, Elizabeth; Parra, Mercedes Macias; Morayta, Alfredo; Dos Santos, Boaneventura Antonio; Maia, Tania Maria Rohde; Pimentel, Analiria; Chavez, Ana; Gatica, Luis Eduardo; Soza, Guillermo; Tassara, Enzo; Villaroel, Julita; Wu, Elba; Apra, Ernestina; Tregnaghi, Miguel; Venter, Andre; Cooper, Peter A.; Cotton, Mark F.; Madhi, Shabir; Karaszi, Julia.

In: Pediatric Infectious Disease Journal, Vol. 21, No. 1, 2002, p. 14-22.

Research output: Contribution to journalArticle

Sáez-Llorens, X, McCoig, C, Feris, JM, Vargas, SL, Klugman, KP, Hussey, GD, Frenck, RW, Falleiros-Carvalho, LH, Arguedas, AG, Bradley, J, Arrieta, AC, Wald, ER, Pancorbo, S, McCracken, GH, Azimi, P, Kelley, R, LaVia, WV, Meissner, C, Noel, G, Overturf, GD, Rathore, M, Castaño, E, Parra, MM, Morayta, A, Dos Santos, BA, Maia, TMR, Pimentel, A, Chavez, A, Gatica, LE, Soza, G, Tassara, E, Villaroel, J, Wu, E, Apra, E, Tregnaghi, M, Venter, A, Cooper, PA, Cotton, MF, Madhi, S & Karaszi, J 2002, 'Quinolone treatment for pediatric bacterial meningitis: A comparative study of trovafloxacin and ceftriaxone with or without vancomycin', Pediatric Infectious Disease Journal, vol. 21, no. 1, pp. 14-22. https://doi.org/10.1097/00006454-200201000-00004
Sáez-Llorens, Xavier ; McCoig, Cynthia ; Feris, Jesús M. ; Vargas, Sergio L. ; Klugman, Keith P. ; Hussey, Gregory D. ; Frenck, Robert W. ; Falleiros-Carvalho, Luisa H. ; Arguedas, Adriano G. ; Bradley, John ; Arrieta, Antonio C. ; Wald, Ellen R. ; Pancorbo, Salvador ; McCracken, George H. ; Azimi, Parvin ; Kelley, Robin ; LaVia, William V. ; Meissner, Cody ; Noel, Gary ; Overturf, Gary D. ; Rathore, Mobeen ; Castaño, Elizabeth ; Parra, Mercedes Macias ; Morayta, Alfredo ; Dos Santos, Boaneventura Antonio ; Maia, Tania Maria Rohde ; Pimentel, Analiria ; Chavez, Ana ; Gatica, Luis Eduardo ; Soza, Guillermo ; Tassara, Enzo ; Villaroel, Julita ; Wu, Elba ; Apra, Ernestina ; Tregnaghi, Miguel ; Venter, Andre ; Cooper, Peter A. ; Cotton, Mark F. ; Madhi, Shabir ; Karaszi, Julia. / Quinolone treatment for pediatric bacterial meningitis : A comparative study of trovafloxacin and ceftriaxone with or without vancomycin. In: Pediatric Infectious Disease Journal. 2002 ; Vol. 21, No. 1. pp. 14-22.
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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

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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

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