Moxifloxacin in pediatric patients with complicated intra-abdominal infections results of the MOXIPEDIA randomized controlled study

Sherif G.S. Emil, Stefan Wirth, Arnis Eņģelis, Valeri Digtyar, Margarita Criollo, Carl DiCasoli, Heino Stass, Stefan Willmann, Richard Nkulikiyinka, Ulrike Grossmann

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

Abstract

Background: This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intraabdominal 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.

Original languageEnglish
Pages (from-to)E207-E213
JournalPediatric Infectious Disease Journal
Volume37
Issue number8
DOIs
Publication statusPublished - 1 Aug 2018
Externally publishedYes

Keywords*

  • Comparator
  • Complicated intra-abdominal infection
  • Moxifloxacin
  • Pediatric patients
  • Safety

Field of Science*

  • 3.2 Clinical medicine
  • 3.3 Health sciences

Publication Type*

  • 1.1. Scientific article indexed in Web of Science and/or Scopus database

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