Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.

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.

Appendicitis in children treated by pediatric versus general surgeons.

BACKGROUND: Pediatric appendicitis is treated by both pediatric and general surgeons. We investigated whether specialty-dependent differences existed in patients' characteristics and outcomes. STUDY DESIGN: A retrospective chart review of 465 consecutive children treated for appendicitis at a university-affiliated children's hospital during a 28-month period was performed. Characteristics and outcomes of patients treated by pediatric surgeons were compared with those treated by general surgeons. Rates of misdiagnosis, postoperative readmission, wound infection, intraabdominal infection, and duration of hospital stay were considered primary outcomes and analyzed by chi-square, Fisher's exact test, or Student's t-test where appropriate. Hospital charges were considered secondary outcomes and analyzed by Wilcoxon rank sum test. RESULTS: Three hundred four children (65%) were treated by pediatric surgeons and 161 (35%) by general surgeons. Pediatric-surgeon patients were younger (8.3 +/- 3.6 versus 13.2 +/- 3.1 years, p < 0.001), and more likely to have gangrenous or perforated appendicitis (54% versus 33%, p < 0.001). There was no significant difference in the normal appendix rate (pediatric surgeon, 4.3% versus general surgeon, 5.6%, p = 0.53). In patients with simple and complicated appendicitis, there were no significant differences between pediatric and general surgeons in readmissions, postoperative complications, or hospital stay. Median hospital charges were not significantly different for complicated appendicitis, but were lower for pediatric-surgeon patients with simple appendicitis (10,735 dollars versus 11,613 dollars, p = 0.005). CONCLUSIONS: Pediatric surgeons treat younger children with more severe appendicitis. There are no specialty-dependent differences in clinical outcomes for simple or complicated appendicitis. Hospital charges are lower for simple appendicitis treated by pediatric surgeons.