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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03380793
• Other study ID #: HS-10090-402
• Status: Recruiting
• Phase: Phase 4
• First received: November 28, 2017
• Last updated: December 19, 2017
• Start date: September 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2017
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Yun Tang
• Phone: 13701393663
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 614
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• morinidazole
morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure Rate	Clinical cure Rate (according to symptoms and signs) at 5-10 days post-therapy	5-10 days
Secondary	Bacteriological response(Bacterial elimination rate)	Bacteriological response (on the first day post-therapy, at 5-10 days post-therapy)	5-10 days
Secondary	Clinical cure Rate on the first day	Clinical cure Rate(according to symptoms and signs)on the first day post-therapy	the first day
Secondary	Tissue distribution	Tissue distribution of target organ(Tissue of the appendix)	5-10 days
Secondary	PPK parameters	Area under the plasma concentration versus time curve (AUC) of morinidazole	5-10 days