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

Hansoh Pharma

Status and phase

Unknown

Phase 4

Conditions

Appendicitis

Treatments

Drug: morinidazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT03380793

HS-10090-402

Details and patient eligibility

About

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

Full 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.

Enrollment

614 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 and 65 years old
A diagnosis of suppurative or gangrenous appendicitis based on:
1. metastatic right lower abdominal pain
2. lower abdominal tenderness and/or rebound tenderness
3. pyrexia (axillary temperature ≥ 37.5 °C), a WBC > 10*109/L on routine blood examination
4. Voluntary signing of written informed consent

Exclusion criteria

patients with an allergy to nitroimidazole
patients with a history of antibiotic therapy within the last 48 hours
patients with any condition likely to require broad spectrum antibiotics
patients who can not evaluate the efficacy or difficult to complete the desired course of treatment
ALT and / or AST ≥ 1.5 times the ULN, and / or serum creatinine ≥ the ULN
patients with severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy)
patients with other diseases or use other drugs which may interfere with the efficacy or safety of the drug
patients who participated other clinical trials within 6 months before the start of the trial
Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive