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

Primary Purpose

Appendicitis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
morinidazole
Sponsored by
Jiangsu Hansoh Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

morinidazole

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical cure Rate
Clinical cure Rate （according to symptoms and signs） at 5-10 days post-therapy

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2017
Last Updated
December 19, 2017
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03380793
Brief Title
A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
614 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
morinidazole
Arm Type
Experimental
Arm Description
morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.
Intervention Type
Drug
Intervention Name(s)
morinidazole
Intervention Description
morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.
Primary Outcome Measure Information:
Title
Clinical cure Rate
Description
Clinical cure Rate （according to symptoms and signs） at 5-10 days post-therapy
Time Frame
5-10 days
Secondary Outcome Measure Information:
Title
Bacteriological response（Bacterial elimination rate）
Description
Bacteriological response (on the first day post-therapy, at 5-10 days post-therapy)
Time Frame
5-10 days
Title
Clinical cure Rate on the first day
Description
Clinical cure Rate（according to symptoms and signs）on the first day post-therapy
Time Frame
the first day
Title
Tissue distribution
Description
Tissue distribution of target organ（Tissue of the appendix）
Time Frame
5-10 days
Title
PPK parameters
Description
Area under the plasma concentration versus time curve (AUC) of morinidazole
Time Frame
5-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 and 65 years old A diagnosis of suppurative or gangrenous appendicitis based on: metastatic right lower abdominal pain lower abdominal tenderness and/or rebound tenderness pyrexia (axillary temperature ≥ 37.5 °C), a WBC > 10*109/L on routine blood examination 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Tang
Phone
13701393663
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Tang
Phone
13701393663

12. IPD Sharing Statement

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

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