NCT03380793

A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis

An Open-Lable Multicenter Prospective Non-Randomized Trial to Assess the Efficacy and Safety of Morinidazole With Surgery in Patients With Suppurative or Gangrenous Appendicitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 614 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with surgery in patients with suppurative or gangrenous appendicitis

Detailed description

Acute appendicitis is among the most common cause of acute abdominal pain. In patients with complicated acute appendicitis, postoperative, broad-spectrum antibiotics are always recommended. 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 pelvic inflammatory disease or appendicitis cases had been approved by CFDA in 2014. This phase 4 study is to assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole in patients with suppurative or gangrenous appendicitis.

Conditions

• Appendicitis

Interventions

Type	Name	Description
DRUG	morinidazole	morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-12-21
• Last updated: 2017-12-21

Locations

1 site across 1 country: China