PMID- 29356761
OWN - NLM
STAT- MEDLINE
DCOM- 20190509
LR  - 20190509
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 37
IP  - 8
DP  - 2018 Aug
TI  - Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: 
      Results of the MOXIPEDIA Randomized Controlled Study.
PG  - e207-e213
LID - 10.1097/INF.0000000000001910 [doi]
AB  - 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.
FAU - Wirth, Stefan
AU  - Wirth S
AD  - From the Department of Pediatrics, HELIOS Medical Center, Wuppertal, Germany.
FAU - Emil, Sherif G S
AU  - Emil SGS
AD  - Department of Pediatric Surgery, The Montreal Children's Hospital of the McGill 
      University Health Centre, Montreal, Quebec, Canada.
FAU - Engelis, Arnis
AU  - Engelis A
AD  - University Children's Hospital, Children's Surgery Department, Riga, Latvia.
FAU - Digtyar, Valeri
AU  - Digtyar V
AD  - Regional Children Clinical Hospital, Dnepropetrovsk, Ukraine.
FAU - Criollo, Margarita
AU  - Criollo M
AD  - Bayer Inc, Mississauga, Ontario, Canada.
FAU - DiCasoli, Carl
AU  - DiCasoli C
AD  - Bayer, Whippany, New Jersey.
FAU - Stass, Heino
AU  - Stass H
AD  - Bayer AG, Wuppertal, Germany.
FAU - Willmann, Stefan
AU  - Willmann S
AD  - Bayer AG, Wuppertal, Germany.
FAU - Nkulikiyinka, Richard
AU  - Nkulikiyinka R
AD  - Bayer AG, Berlin, Germany.
FAU - Grossmann, Ulrike
AU  - Grossmann U
AD  - Bayer AG, Berlin, Germany.
CN  - MOXIPEDIA Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01049022
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Anti-Bacterial Agents)
RN  - 74469-00-4 (Amoxicillin-Potassium Clavulanate Combination)
RN  - U188XYD42P (Moxifloxacin)
SB  - IM
MH  - Administration, Intravenous
MH  - Adolescent
MH  - Amoxicillin-Potassium Clavulanate Combination/adverse effects/therapeutic use
MH  - Anti-Bacterial Agents/adverse effects/*therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Infant
MH  - Intraabdominal Infections/*complications/*drug therapy/microbiology
MH  - Male
MH  - Moxifloxacin/adverse effects/*therapeutic use
MH  - Prospective Studies
EDAT- 2018/01/23 06:00
MHDA- 2019/05/10 06:00
CRDT- 2018/01/23 06:00
PHST- 2018/01/23 06:00 [pubmed]
PHST- 2019/05/10 06:00 [medline]
PHST- 2018/01/23 06:00 [entrez]
AID - 10.1097/INF.0000000000001910 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2018 Aug;37(8):e207-e213. doi: 
      10.1097/INF.0000000000001910.