Clinical trial NCT06828874: A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria
Official title: A Prospective, Multicenter, Randomized, Blinded, Positive Parallel Control Study to Estimate the Efficacy and Safety of Levornidazole Disodium Phosphate for Injection in the Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraabdominal Infections
Lead sponsor: Yangtze River Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria：

Subjects who meet all of the following criteria may be enrolled in the study:

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：

Subjects who meet any of the following criteria should be excluded from this study:

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

Primary outcomes:
measure: Proportion of participants with clinical cure at Test of Cure (TOC) visit
timeFrame: 5 to 10 days post-therapy
Secondary outcomes:
measure: Proportion of participants with clinical cure at End of Therapy (EOT) visit
timeFrame: Up to approximately Day 8
measure: Bacteriological efficacy at EOT visit
timeFrame: Up to approximately Day 8
measure: Comprehensive efficacy at EOT visit
timeFrame: Up to approximately Day 8
measure: Bacteriological efficacy at TOC visit
timeFrame: 5 to 10 days post-therapy
measure: Comprehensive efficacy at TOC visit
timeFrame: 5 to 10 days post-therapy
measure: Incidence of phlebitis during treatment
timeFrame: Up to approximately Day 7
measure: Percentage of participants who experienced Adverse Events (AEs)
timeFrame: Up to Day 10 post-therapy
Other outcomes:
Locations:
city: Chizhou
country: China
facility: Chizhou People's Hospital
state: Anhui
city: Fuyang
country: China
facility: Taihe County People's Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Third Xiangya Hospital of Central South University
state: Hunan
city: Shaoyang
country: China
facility: The First Affiliated Hospital of Shaoyang University
state: Hunan
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
city: Wuxi
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Yixing People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital of Traditional Chinese Medicine
state: Shandong
city: Rizhao
country: China
facility: Rizhao People's Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Jinhua
country: China
facility: Dongyang People's Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua People's Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
Study officials:
References: