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Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized
Stefan Wirth1, Sherif G S Emil2, Arnis Engelis3
1From the Department of Pediatrics, HELIOS Medical Center, Wuppertal, Germany.
Insights
Moxifloxacin (MXF) showed comparable safety to comparator antibiotics in children with complicated intra-abdominal infections (cIAIs). However, MXF demonstrated a lower clinical cure rate, making it not recommended when alternatives are available.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology and Therapeutics
- Clinical Microbiology
Background:
- Complicated intra-abdominal infections (cIAIs) in children require effective and safe antimicrobial therapy.
- Evaluating novel antibiotic options like moxifloxacin (MXF) is crucial for pediatric infectious disease management.
Purpose of the Study:
- To assess the safety and efficacy of moxifloxacin (MXF) in pediatric patients diagnosed with complicated intra-abdominal infections (cIAIs).
Main Methods:
- A multicenter, randomized, double-blind, controlled trial involving 451 pediatric patients (3 months to 17 years) with cIAIs.
- Patients received intravenous/oral MXF or a comparator regimen (ertapenem followed by amoxicillin/clavulanate) for 5-14 days.
- Primary endpoint was safety (cardiac, musculoskeletal), with secondary endpoints including clinical and bacteriologic efficacy.
Main Results:
- Adverse event proportions were similar between MXF and comparator groups (58.1% vs. 54.7%).
- Drug-related adverse events were more frequent with MXF (14.3%) compared to the comparator (6.7%).
- Clinical cure rates were lower for MXF (84.6%) versus the comparator (95.5%) in patients with confirmed pathogens.
Conclusions:
- Moxifloxacin (MXF) was generally well-tolerated in pediatric patients with cIAIs.
- The observed lower clinical cure rate suggests MXF is less effective than the comparator for this indication.
- MXF is not recommended for pediatric cIAIs if more efficacious antibiotics with a better safety profile are available.
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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