Appendicitis Clinical Trial
Official title:
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
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
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Recruiting |
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| Completed |
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| Completed |
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Phase 2 | |
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