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A Trial to Assess the Efficacy and Safety of Morinidazole in Women With Pelvic Inflammatory Disease

Pelvic Inflammatory Disease Clinical Trial

Official title:
An Open-Lable Multicenter Prospective Non-Randomized Trial to Assess the Efficacy and Safety of Morinidazole With Levofloxacin and Sequential of Levofloxacin in Women With Pelvic Inflammatory Disease

Clinical Trial Summary

To assess the efficacy, safety and Population Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with levofloxacin hydrochloride and sodium chloride injection sequential of levofloxacin hydrochloride tablets in women with pelvic inflammatory disease: An Open-Lable Multicenter Prospective Non-Randomized Trial

Clinical Trial Description

Pelvic inflammatory disease (PID) is a spectrum of upper genital tract inflammations comprising endometritis, salpingitis, parametritis, oophoritis, tubo-ovarian abscess and/or pelvic peritonitis. The objectives of administering antimicrobial therapy in patients with PID are to control the symptoms and to prevent the late sequelae of the disease. Because anaerobe infections (e.g., Bacteroides fragilis infections) are associated with tubal and epithelial damage, anaerobic coverage is routinely recommended in women with pelvic infection. Guidelines have been developed in both the USA and Europe with regard to PID management. Metronidazole, a member of the nitroimidazole drug class, is included in the regimens recommended for improving anaerobic bacteria coverage. The sideeffects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. Antimicrobial resistance to metronidazole has emerged after several decades of worldwide use of the drug. Morinidazole, a National Class I Antimicrobial, is a new type of third-generation nitroimidazole antimicrobial that is used for treating amoebiasis, trichomoniasis, and anaerobic bacterial infections, and which exhibits greater activity and less toxicity than metronidazole.

Morinidazole and Sodium Chloride Injection used in PID or appendicitis cases had been approved by CFDA in 2014. This phase 4 study is to assess the efficacy, safety and Population Pharmacokinetic (PPK) of morinidazole in PID. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03391440
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Shixuan Wang
Phone 02783663078
Status Recruiting
Phase Phase 4
Start date September 2016
Completion date December 2018
View Details
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