A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria

NCT06828874 | Completed Phase 4

• 1 other identifier: YRPG-PMS-XR-RCT-2022-03
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 32

Brief Summary

Anaerobic infections are very common in clinical practice. Poor control of anaerobic infections in patients undergoing abdominal surgery may lead to the occurrence of complications. The aim of this study is to explore the efficacy and safety of Levornidazole Phosphate Disodium for Injection in the treatment of patients with postoperative intra-abdominal infections caused by anaerobic bacteria.

Conditions

Intraabdominal Infections

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with clinical cure at Test of Cure (TOC) visit

  Clinical cure was defined as complete resolution of all symptoms and signs, including the return to normal of non - microbiological indicators such as preoperative imaging and laboratory tests. Symptoms and laboratory tests returned to normal using the following criteria: resolution or improvement of abdominal pain; Body temperature ≤ 37.5°C and white blood cell count \< 10×10\^9/L. persistent or incomplete resolution or worsening of symptoms and signs; or the development of new symptoms or signs and/or the use of other antimicrobial drugs against anaerobes was defined as clinically failure. The percentage of participants with clinical cure or clinical failure at TOC was summarized.

  5 to 10 days post-therapy

Secondary Outcomes (7)

• Proportion of participants with clinical cure at End of Therapy (EOT) visit

  Up to approximately Day 8

• Bacteriological efficacy at EOT visit

  Up to approximately Day 8

• Comprehensive efficacy at EOT visit

  Up to approximately Day 8

• Bacteriological efficacy at TOC visit

  5 to 10 days post-therapy

• Comprehensive efficacy at TOC visit

  5 to 10 days post-therapy

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: Levornidazole Disodium Phosphate for Injection

Control Group

ACTIVE COMPARATOR

Drug: Ornidazole and Sodium Chloride Injection

Interventions

Levornidazole Disodium Phosphate for Injection DRUG

1g，once daily, intravenously guttae for 4 to 7 days

Experimental Group

Ornidazole and Sodium Chloride Injection DRUG

0.5g at a time , 2 times per day, intravenously guttae for 4 to 7 days

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet all of the following criteria may be enrolled in the study:
• Age between 18 and 75 years old
• Requires minimally invasive surgery (laparoscopic surgery or robotic-assisted surgery), open or percutaneous drainage surgery; Intra-abdominal infection caused by anaerobic bacteria as judged by the investigator, including purulent appendicitis, gangrene perforated appendicitis, periappendiceal abscess, gastric or duodenal perforation or rupture, jejunum, ileum, colorectal perforation or rupture, acute biliary tract infection and liver abscess; and meet at least one of the following two criteria: (1)At least two of the following four conditions must be met within 24 hours before surgery: abdominal pain, tenderness and fever (axillary temperature ≥ 37.5℃); white blood cell count ≥ 10×10\^9/L; C-reactive protein above the upper limit of normal; procalcitonin (PCT)above the upper limit of normal;(2) Computed Tomography (CT) or ultrasound confirms the presence of intra-abdominal infection
• Agree or plan to use the investigational drug for the first time within 24 hours postoperatively
• The subjects voluntarily underwent the test and signed the informed consent form, and the process of signing the informed consent form was in line with Good Clinical Practice (GCP) guidelines

You may not qualify if:

• Subjects who meet any of the following criteria should be excluded from this study:
• Those with known or suspected allergies to nitroimidazoles
• Patients who have participated in other studies and used investigational drugs of other studies within 3 months prior to screening
• Patients who are taking other medications or have other diseases that may interfere with the evaluation of the safety or effectiveness of the drug; Or patients who are at risk of serious drug interactions due to concomitant medications(such as warfarin, as well as medications with compatibility contraindications to levornidazole, including furbencillin sodium, nafcillin sodium, omeprazole, vorbizole, potassium sodium dehydroandrographolide succinate for injection, azlocillin sodium, etc.)
• patients who have poor compliance and cannot complete the expected course of treatment and follow-up in the opinion of the investigator
• Abnormal liver function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 times the upper limit of the normal value; for patients with acute biliary tract infection or combined liver abscess, it can be relaxed to \> 3 times the upper limit of the normal value); or abnormal kidney function (creatinine clearance rate ≤ 60 mL/min/1.73 m² \[Cockcroft - Gault formula\])
• Patients with serious primary diseases of important organs and systems such as cardiovascular, nervous system, endocrine system, hematopoietic system (such as heart failure, leukemia, uncontrolled diabetes, etc.), or those with malignant tumors
• Women during pregnancy or lactation, or women of childbearing age with a positive pregnancy test result before the trial
• Women of childbearing age and men who cannot take effective contraceptive measures during the trial period. The time limit is from the signing of the informed consent form to 3 months after the last dose
• Patients with infections other than the abdomen (chronic infections that do not affect the evaluation of intra-abdominal infections \[such as chronic rhinitis, chronic pharyngitis, etc.\] can be included in this study)
• Patients with multiple organ failure
• Those who are considered by the investigator to be severely ill and need to be treated with other broad-spectrum antibiotics with anti-anaerobic effects (except for first/second/third generation cephalosporins, aztreonam, quinolones, aminoglycosides).
• Those who have received antibiotic treatment within 48 hours before enrollment and randomization(except for single dose)
• Those with positive test results for hepatitis B surface antigen, acquired immunodeficiency syndrome (AIDS) antibody, treponema pallidum antibody, and hepatitis C antibody
• Patients with lesions of the brain and spinal cord, epilepsy, organ sclerosis, hematopoietic insufficiency, chronic alcoholism

Sponsors & Collaborators

• Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd: lead

Study Sites (32)

Chizhou People's Hospital

Chizhou, Anhui, China

Location

Taihe County People's Hospital

Fuyang, Anhui, China

Location

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

People's Hospital of Wuhan University

Wuhan, Hubei, China

Location

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Shaoyang University

Shaoyang, Hunan, China

Location

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Location

Jiangyin People's Hospital

Wuxi, Jiangsu, China

Location

Yixing People's Hospital

Wuxi, Jiangsu, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Location

Shandong Provincial Hospital of Traditional Chinese Medicine

Jinan, Shandong, China

Location

Rizhao People's Hospital

Rizhao, Shandong, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Dongyang People's Hospital

Jinhua, Zhejiang, China

Location

Jinhua People's Hospital

Jinhua, Zhejiang, China

Location

Lishui People's Hospital

Lishui, Zhejiang, China

Location

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Injections; Ornidazole; Sodium Chloride

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 17, 2025
• Study Start: May 10, 2023
• Primary Completion: September 23, 2024
• Study Completion: October 14, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CN (32)