Intraabdominal InfectionsPhase 4NCT06828874
A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria
A Phase 4 study testing Levornidazole Disodium Phosphate for Injection and Ornidazole and Sodium Chloride Injection in people with Intraabdominal Infections, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 32 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intraabdominal Infections
- What is being tested?
- Levornidazole Disodium Phosphate for Injection and Ornidazole and Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 696 participants
- Where
- 32 sitesChina
- Study dates
- 10 May 2023to 14 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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])
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- 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
- Other patients who are not suitable to participate in this clinical study in the opinion of the investigator
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Beijing Anzhen Hospital
Beijing, Beijing Municipality
Beijing Friendship Hospital
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
Third Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Chizhou People's Hospital
Chizhou, Anhui
Taihe County People's Hospital
Fuyang, Anhui
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Guizhou Provincial People's Hospital
Guiyang, Guizhou
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Shandong Provincial Hospital of Traditional Chinese Medicine
Jinan, Shandong
Dongyang People's Hospital
Jinhua, Zhejiang
Jinhua People's Hospital
Jinhua, Zhejiang
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Lishui People's Hospital
Lishui, Zhejiang
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian
Rizhao People's Hospital
Rizhao, Shandong
The First Affiliated Hospital of Shaoyang University
Shaoyang, Hunan
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Shanxi Bethune Hospital
Taiyuan, Shanxi
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
People's Hospital of Wuhan University
Wuhan, Hubei
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Jiangyin People's Hospital
Wuxi, Jiangsu
Yixing People's Hospital
Wuxi, Jiangsu
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
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
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
- Being tested
- Levornidazole Disodium Phosphate for Injection, Ornidazole and Sodium Chloride Injection
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levornidazole Disodium Phosphate for InjectionDrug
1g，once daily, intravenously guttae for 4 to 7 days
Ornidazole and Sodium Chloride InjectionDrug
0.5g at a time , 2 times per day, intravenously guttae for 4 to 7 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: Levornidazole Disodium Phosphate for Injection |
| Control Group | Active comparator | Not described Receives: Drug: Ornidazole and Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 to 10 days post-therapy
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 10 post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start10 May 2023
- Primary completion23 Sep 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828874
- Sponsor's protocol ID
- YRPG-PMS-XR-RCT-2022-03
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06828874
- Acronym / sponsor ID
- YRPG-PMS-XR-RCT-2022-03
- Conditions
- Intraabdominal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Levornidazole Disodium Phosphate for Injection |
| Control Group | Active comparator | Drug: Ornidazole and Sodium Chloride Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levornidazole Disodium Phosphate for Injection1g，once daily, intravenously guttae for 4 to 7 days | Drug | Experimental Group |
| Ornidazole and Sodium Chloride Injection0.5g at a time , 2 times per day, intravenously guttae for 4 to 7 days | Drug | Control Group |
Primary outcome
Proportion of participants with clinical cure at Test of Cure (TOC) visit
Time frame: 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.
7 secondary outcomes
Proportion of participants with clinical cure at End of Therapy (EOT) visit
Time frame: Up to approximately Day 8
Bacteriological efficacy at EOT visit
Time frame: Up to approximately Day 8
Comprehensive efficacy at EOT visit
Time frame: Up to approximately Day 8
Bacteriological efficacy at TOC visit
Time frame: 5 to 10 days post-therapy
Comprehensive efficacy at TOC visit
Time frame: 5 to 10 days post-therapy
Incidence of phlebitis during treatment
Time frame: Up to approximately Day 7
Percentage of participants who experienced Adverse Events (AEs)
Time frame: Up to Day 10 post-therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levornidazole Disodium Phosphate for Injection and Ornidazole and Sodium Chloride Injection in people with Intraabdominal Infections, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 32 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with clinical cure at Test of Cure (TOC) visit (time frame: 5 to 10 days post-therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.