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

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

Study Overview

• Status: Unknown
• Conditions: Appendicitis
• Intervention / Treatment: Drug: morinidazole

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.

• Study Type: Interventional
• Enrollment (Anticipated): 614
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yun Tang; Phone Number: 13701393663

Study Locations

• China
  • Beijing, China, 100853
    • Recruiting
    • PLA General Hospital
    • Contact: Yun Tang; Phone Number: 13701393663

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: morinidazole; morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.	Drug: morinidazole; morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure Rate	Clinical cure Rate （according to symptoms and signs） at 5-10 days post-therapy	5-10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: HS-10090-402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No