Efficacy and Safety of Moxifloxacin in Hospitalized Patients with Secondary Peritonitis: Pooled Analysis of Four Randomized Phase III Trials

Abstract

Background: Secondary peritonitis is an advanced form of complicated intra-abdominal infection (cIAI) requiring hospitalization, surgical source control, and empiric antibiotic therapy against causative aerobic and anaerobic bacteria.Methods: This pooled analysis of four prospective, active-controlled randomized clinical trials compared the efficacy and safety of moxifloxacin with that of comparator antibiotics in patients with confirmed secondary peritonitis. The primary efficacy endpoint was clinical success rate at test-of-cure (TOC) between day 10 and 45 post-therapy in the per-protocol (PP) population. Safety and clinical efficacy were assessed also in the intent-totreat population (ITT). Bacteriological success was assessed at TOC in the microbiologically-valid population as a secondary efficacy endpoint. Results: Overall clinical success rates at TOC were 85.3% (431 of 505 patients) in the moxifloxacin and 88.4% (459 of 519 patients) in the comparator treatment groups (PP population, point estimate for the difference in success rates: -3.0%; 95% CI -7.06%, 1.05%), respectively. Similar clinical success rates between moxifloxacin and comparators were observed by anatomical site of infection, and ranged from 80.6% to 100% for moxifloxacin and from 71.4% to 96.6% for comparators, respectively. Bacteriologic success rates were similar with moxifloxacin (82.4%) and comparators (86.8%), respectively. The proportion of patients experiencing any treatment-emergent adverse events was slightly higher with moxifloxacin (67.3%) versus comparators (59.8%). Rates of drug-related adverse events (20.9% versus 20.0%) and deaths (4.3% versus 3.4%) were similar in moxifloxacin and comparator groups; none of the deaths were drug-related. Conclusions: The data suggests that once-daily IV (or IV/PO) moxifloxacin has a comparable efficacy and safety profile to antibiotic regimens approved previously in the subgroup of patients with secondary peritonitis of mild-to-moderate severity.

Spectrum adequacy of antibiotic regimens for secondary peritonitis: a retrospective analysis in intermediate and intensive care unit patients

“…Although data quality (with regard to patient characteristics and diagnostic procedures) may be highest in clinical trials e.g. of new antimicrobial agents, such studies are likely to represent a highly selected population of tendentially less severe cases (particularly appendicitis) in younger and healthier patients than encountered in clinical practice [ 9 , 10 ]. For the present study, the most important criterion for inclusion was admission to the surgical IMCU/ICU.…”

Penatalaksanaan Syok Sepsis dengan Penyulit Cedera Ginjal Akut pada Pasien Peritonitis Sekunder

“…Inilah alasan dilakukan resusitasi sebelum tindakan apapun seperti pada kasus ini. [2][3][4][8][9][10][11] Setelah diresusitasi dilakukan laparatomi dan ditemukan tumor yang kemudian direseksi dan dilakukan anastomosis dan ileocolostomy selama 4 jam. Pascaoperasi pasien ditransfer ke ICU dalam keadaan terintubasi ETT oral.…”