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Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.
Wirth, Stefan; Emil, Sherif G S; Engelis, Arnis; Digtyar, Valeri; Criollo, Margarita; DiCasoli, Carl; Stass, Heino; Willmann, Stefan; Nkulikiyinka, Richard; Grossmann, Ulrike.
Afiliación
  • Wirth S; From the Department of Pediatrics, HELIOS Medical Center, Wuppertal, Germany.
  • Emil SGS; Department of Pediatric Surgery, The Montreal Children's Hospital of the McGill University Health Centre, Montreal, Quebec, Canada.
  • Engelis A; University Children's Hospital, Children's Surgery Department, Riga, Latvia.
  • Digtyar V; Regional Children Clinical Hospital, Dnepropetrovsk, Ukraine.
  • Criollo M; Bayer Inc, Mississauga, Ontario, Canada.
  • DiCasoli C; Bayer, Whippany, New Jersey.
  • Stass H; Bayer AG, Wuppertal, Germany.
  • Willmann S; Bayer AG, Wuppertal, Germany.
  • Nkulikiyinka R; Bayer AG, Berlin, Germany.
  • Grossmann U; Bayer AG, Berlin, Germany.
Pediatr Infect Dis J ; 37(8): e207-e213, 2018 08.
Article en En | MEDLINE | ID: mdl-29356761
BACKGROUND: This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs). METHODS: In this multicenter, randomized, double-blind, controlled study, 451 pediatric patients aged 3 months to 17 years with cIAIs were treated with intravenous/oral MXF (N = 301) or comparator (COMP, intravenous ertapenem followed by oral amoxicillin/clavulanate; N = 150) for 5 to 14 days. Doses of MXF were selected based on the results of a Phase 1 study in pediatric patients (NCT01049022). The primary endpoint was safety, with particular focus on cardiac and musculoskeletal safety; clinical and bacteriologic efficacy at test of cure was also investigated. RESULTS: The proportion of patients with adverse events (AEs) was comparable between the 2 treatment arms (MXF: 58.1% and COMP: 54.7%). The incidence of drug-related AEs was higher in the MXF arm than in the COMP arm (14.3% and 6.7%, respectively). No cases of QTc interval prolongation-related morbidity or mortality were observed. The proportion of patients with musculoskeletal AEs was comparable between treatment arms; no drug-related events were reported. Clinical cure rates were 84.6% and 95.5% in the MXF and COMP arms, respectively, in patients with confirmed pathogen(s) at baseline. CONCLUSIONS: MXF treatment was well tolerated in children with cIAIs. However, a lower clinical cure rate was observed with MXF treatment compared with COMP. This study does not support a recommendation of MXF for children with cIAIs when alternative more efficacious antibiotics with better safety profile are available.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones Intraabdominales / Moxifloxacino / Antibacterianos Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Revista: Pediatr Infect Dis J Asunto de la revista: DOENCAS TRANSMISSIVEIS / PEDIATRIA Año: 2018 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones Intraabdominales / Moxifloxacino / Antibacterianos Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Revista: Pediatr Infect Dis J Asunto de la revista: DOENCAS TRANSMISSIVEIS / PEDIATRIA Año: 2018 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos