Efficacy and safety of morinidazole in pelvic inflammatory disease: results of a multicenter, double-blind, randomized trial.
Chen CaoA LuoP WuD WengH ZhengS WangPublished in: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology (2017)
This multicenter, double-blind, randomized, parallel-group, non-inferiority study compared the efficacy and safety of morinidazole with those of ornidazole in women with pelvic inflammatory disease. Women from 18 hospitals in China received a 14-day course of either intravenous morinidazole, 500 mg twice daily (n = 168), or intravenous ornidazole, 500 mg twice daily (n = 170). A total of 312 of 338 patients in the full analysis set (FAS) (92.3%) were included in the per protocol set (PPS) analyses, 61 (19.6%) of whom were included in the microbiologically valid (MBV) population. The clinical resolution rates in the PPS population at the test of cure (TOC, primary efficacy end point, 7-30 days post-therapy) visit were 96.86% (154/159) for morinidazole and 96.73% (148/153) for ornidazole (95% CI: -3.79% to 4.03%). The bacteriological success rates in the MBV population at the TOC visit were 100% (32/32) for morinidazole and 89.66% (26/29) for ornidazole (95% CI: -16.15% to 11.21%). Drug-related adverse events occurred less frequently with morinidazole (32.74%, 55/168) than with ornidazole (47.06%, 80/170) (p < 0.01). For women with pelvic inflammatory disease, twice-daily morinidazole for 14 days was clinically and bacteriologically as efficacious as twice-daily ornidazole for 14 days, while the former was associated with fewer drug-related adverse events than the latter.
Keyphrases
- double blind
- placebo controlled
- clinical trial
- physical activity
- phase iii
- end stage renal disease
- rectal cancer
- oxidative stress
- study protocol
- randomized controlled trial
- newly diagnosed
- healthcare
- chronic kidney disease
- phase ii
- high dose
- ejection fraction
- open label
- type diabetes
- cross sectional
- peritoneal dialysis
- skeletal muscle
- low dose
- polycystic ovary syndrome
- pregnant women
- insulin resistance
- single molecule
- patient reported