A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria
NCT ID: NCT06828874
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
696 participants
INTERVENTIONAL
2023-05-10
2024-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group
Levornidazole Disodium Phosphate for Injection
1g，once daily, intravenously guttae for 4 to 7 days
Control Group
Ornidazole and Sodium Chloride Injection
0.5g at a time , 2 times per day, intravenously guttae for 4 to 7 days
Interventions
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Levornidazole Disodium Phosphate for Injection
1g，once daily, intravenously guttae for 4 to 7 days
Ornidazole and Sodium Chloride Injection
0.5g at a time , 2 times per day, intravenously guttae for 4 to 7 days
Eligibility Criteria
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Inclusion Criteria
1. Age between 18 and 75 years old
2. 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
3. Agree or plan to use the investigational drug for the first time within 24 hours postoperatively
4. 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
Exclusion Criteria
1. Those with known or suspected allergies to nitroimidazoles
2. Patients who have participated in other studies and used investigational drugs of other studies within 3 months prior to screening
3. 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.)
4. patients who have poor compliance and cannot complete the expected course of treatment and follow-up in the opinion of the investigator
5. 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 \[Cockcroft - Gault formula\])
6. 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
7. Women during pregnancy or lactation, or women of childbearing age with a positive pregnancy test result before the trial
8. 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
9. 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)
10. Patients with multiple organ failure
11. 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).
12. Those who have received antibiotic treatment within 48 hours before enrollment and randomization(except for single dose)
13. Those with positive test results for hepatitis B surface antigen, acquired immunodeficiency syndrome (AIDS) antibody, treponema pallidum antibody, and hepatitis C antibody
14. Patients with lesions of the brain and spinal cord, epilepsy, organ sclerosis, hematopoietic insufficiency, chronic alcoholism
15. Other patients who are not suitable to participate in this clinical study in the opinion of the investigator
18 Years
75 Years
ALL
No
Sponsors
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Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Locations
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Chizhou People's Hospital
Chizhou, Anhui, China
Taihe County People's Hospital
Fuyang, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Shaoyang University
Shaoyang, Hunan, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Jiangyin People's Hospital
Wuxi, Jiangsu, China
Yixing People's Hospital
Wuxi, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Provincial Hospital of Traditional Chinese Medicine
Jinan, Shandong, China
Rizhao People's Hospital
Rizhao, Shandong, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Dongyang People's Hospital
Jinhua, Zhejiang, China
Jinhua People's Hospital
Jinhua, Zhejiang, China
Lishui People's Hospital
Lishui, Zhejiang, China
Countries
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Other Identifiers
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YRPG-PMS-XR-RCT-2022-03
Identifier Type: -
Identifier Source: org_study_id
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