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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levornidazole Disodium Phosphate for Injection | Drug | 1g,once daily, intravenously guttae for 4 to 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with clinical cure at End of Therapy (EOT) 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. |
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Inclusion criteria:
Subjects who meet all of the following criteria may be enrolled in the study:
Exclusion criteria:
Subjects who meet any of the following criteria should be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chizhou People's Hospital | Chizhou | Anhui | China | |||
| Taihe County People's Hospital |
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| Ornidazole and Sodium Chloride Injection | Drug | 0.5g at a time , 2 times per day, intravenously guttae for 4 to 7 days |
|
| Up to approximately Day 8 |
| Bacteriological efficacy at EOT visit | 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. | Up to approximately Day 8 |
| Comprehensive efficacy at EOT visit | 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. | Up to approximately Day 8 |
| Bacteriological efficacy at TOC visit | 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. | 5 to 10 days post-therapy |
| Comprehensive efficacy at TOC visit | 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. | 5 to 10 days post-therapy |
| Incidence of phlebitis during treatment | 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. | Up to approximately Day 7 |
| Percentage of participants who experienced Adverse Events (AEs) | 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. | Up to Day 10 post-therapy |
| 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 |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D009950 | Ornidazole |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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