amoxicillin-potassium-clavulanate-combination and Intraabdominal-Infections

This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs).. 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.. 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.. 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.

Topics: Administration, Intravenous; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Intraabdominal Infections; Male; Moxifloxacin; Prospective Studies

The aim of this study was to investigate the potential contributory role of laparoscopic appendectomy in the occurrence of postoperative intra-abdominal infections.. A prospective single-center study including 48 patients who underwent laparoscopic appendectomy was conducted between August 2010 and September 2011. Two peritoneal samples were obtained from each patient in the pre- and post-appendectomy period. Aerobic and anaerobic microbiological cultures were obtained from the samples. The data were analyzed with statistical methods.. The mean age of the 48 patients (29 male, 19 female) was 10.9 years. Among the pre-appendectomy aerobic cultures, microorganisms were isolated in 18 of the patients (38%), with Escherichia coli being the most common. In post-appendectomy aerobic cultures, various bacteria were isolated in 7 patients (14.6%), with the numbers of bacteria statistically significantly reduced (p<0.05). Anaerobic microorganisms were isolated in 12 patients (25%) and 4 patients (8.3%) in pre- and post-appendectomy cultures, respectively, with Bacteroides fragilis the most common organism; there was a significant reduction in the bacterial count (p<0.05). Each patient was regarded as their own control.. Our results suggest that laparoscopic appendectomy does not cause an increase in intra-abdominal infections, and particularly not infections associated with anaerobic bacteria.

Topics: Abdominal Abscess; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Appendectomy; Child; Child, Preschool; Escherichia coli; Female; Humans; Intraabdominal Infections; Laparoscopy; Male; Prospective Studies

Escherichia coli is commonly involved in infections with a heavy bacterial burden. Piperacillin-tazobactam and carbapenems are among the recommended empirical treatments for health care-associated complicated intra-abdominal infections. In contrast to amoxicillin-clavulanate, both have reduced in vitro activity in the presence of high concentrations of extended-spectrum β-lactamase (ESBL)-producing and non-ESBL-producing E. coli bacteria. Our goal was to compare the efficacy of these antimicrobials against different concentrations of two clinical E. coli strains, one an ESBL-producer and the other a non-ESBL-producer, in a murine sepsis model. An experimental sepsis model {~5.5 log10 CFU/g [low inoculum concentration (LI)] or ~7.5 log(10) CFU/g [high inoculum concentration (HI)]} using E. coli strains ATCC 25922 (non-ESBL producer) and Ec1062 (CTX-M-14 producer), which are susceptible to the three antimicrobials, was used. Amoxicillin-clavulanate (50/12.5 mg/kg given intramuscularly [i.m.]), piperacillin-tazobactam (25/3.125 mg/kg given intraperitoneally [i.p.]), and imipenem (30 mg/kg i.m.) were used. Piperacillin-tazobactam and imipenem reduced spleen ATCC 25922 strain concentrations (-2.53 and -2.14 log10 CFU/g [P < 0.05, respectively]) in the HI versus LI groups, while amoxicillin-clavulanate maintained its efficacy (-1.01 log10 CFU/g [no statistically significant difference]). Regarding the Ec1062 strain, the antimicrobials showed lower efficacy in the HI than in the LI groups: -0.73, -1.89, and -1.62 log10 CFU/g (P < 0.05, for piperacillin-tazobactam, imipenem, and amoxicillin-clavulanate, respectively, although imipenem and amoxicillin-clavulanate were more efficacious than piperacillin-tazobactam). An adapted imipenem treatment (based on the time for which the serum drug concentration remained above the MIC obtained with a HI of the ATCC 25922 strain) improved its efficacy to -1.67 log10 CFU/g (P < 0.05). These results suggest that amoxicillin-clavulanate could be an alternative to imipenem treatment of infections caused by ESBL- and non-ESBL-producing E. coli strains in patients with therapeutic failure with piperacillin-tazobactam.

Topics: Amoxicillin-Potassium Clavulanate Combination; Animals; Anti-Bacterial Agents; beta-Lactamases; Colony Count, Microbial; Escherichia coli; Escherichia coli Infections; Female; Imipenem; Injections, Intramuscular; Injections, Intraperitoneal; Intraabdominal Infections; Mice; Mice, Inbred C57BL; Microbial Sensitivity Tests; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Sepsis; Treatment Outcome