A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria
- Conditions
- Intraabdominal Infections
- Interventions
- Drug: Ornidazole and Sodium Chloride Injection
- Registration Number
- NCT06828874
- Lead Sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 696
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Ornidazole and Sodium Chloride Injection - Experimental Group Levornidazole Disodium Phosphate for Injection -
- Primary Outcome Measures
Name Time Method Proportion of participants with clinical cure at Test of Cure (TOC) visit 5 to 10 days post-therapy 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.
- Secondary Outcome Measures
Name Time Method Proportion of participants with clinical cure at End of Therapy (EOT) visit Up to approximately Day 8 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.
Bacteriological efficacy at EOT visit Up to approximately Day 8 Bacteriological efficacy included eradication (absence of the baseline bacterial pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a participant who is assessed as a clinical cure). Bacteriological efficacy was evaluated only in cases where anaerobic cultures were positive for specimens obtained during baseline surgery. The percentage of participants with a favorable per-participant microbiological response of eradication or presumed eradication was reported for the EOT visit.
Comprehensive efficacy at EOT visit Up to approximately Day 8 Comprehensive efficacy was evaluated only in cases where anaerobic cultures were positive for specimens obtained during baseline surgery. It was an evaluation based on a combination of clinical and bacteriological results, and was divided into cured and ineffective. The former implied clinical cure with bacteria eradication or presumed eradication. The latter referred to clinical failure or bacterial non-eradication or presumed non-eradication, or both. The percentage of participants who were cured or ineffective was summarized for the EOT visit.
Bacteriological efficacy at TOC visit 5 to 10 days post-therapy Bacteriological efficacy included eradication (absence of the baseline bacterial pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a participant who is assessed as a clinical cure). Bacteriological efficacy was evaluated only in cases where anaerobic cultures were positive for specimens obtained during baseline surgery. The percentage of participants with a favorable per-participant microbiological response of eradication or presumed eradication was reported for the TOC visit.
Comprehensive efficacy at TOC visit 5 to 10 days post-therapy Comprehensive efficacy was evaluated only in cases where anaerobic cultures were positive for specimens obtained during baseline surgery. It was an evaluation based on a combination of clinical and bacteriological results, and was divided into cured and ineffective. The former implied clinical cure with bacteria eradication or presumed eradication. The latter referred to clinical failure or bacterial non-eradication or presumed non-eradication, or both. The percentage of participants who were cured or ineffective was summarized for the TOC visit.
Incidence of phlebitis during treatment Up to approximately Day 7 Phlebitis may be associated with intravenous infusion of highly irritating, high-concentration drugs, or prolonged use, and is one of the safety indicators. The percentage of participants who developed phlebitis was summarized during treatment.
Percentage of participants who experienced Adverse Events (AEs) Up to Day 10 post-therapy An AE was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The percentage of participants who experienced AEs were summarized.
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Trial Locations
- Locations (32)
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, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, 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