A clinical study to evaluate the efficacy and safety of Morinidazole and Sodium Chloride Injection in the treatment of Acute biliary pancreatitis with infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900020552

Enrollment

Unknown

Registered

2019-01-08

Start date

2019-01-07

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute biliary pancreatitis with infection

Interventions

Morinidazole:Cefperazone-Sulbactam, 2.0g, every 12h , ivgtt

Morinidazole, 500mg every q12h for 7to 14days, iv gtt

Metronidazole:Cefperazone-Sulbactam, 2.0g, every 12h, ivgtt

Metronidazole, 500mg every q12h for 7 to 14days, ivgtt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years old, male or female; 2. Acute biliary pancreatitis was diagnosed: (1) It accords with the symptoms and signs of acute pancreatitisPhysical examination showed right upper abdominal tenderness or total abdominal tenderness; (2) Imaging evidence of pancreatic swelling, exudation, necrosis, etc.; (3) B ultrasound, CT or ERCP examination confirmed the presence of biliary tract diseaseseg Cholecystitis, biliary --calculi or biliary tract infection; (4) There is no cause other than biliary tract disease; Concomitant signs of infection: (1) The axillary temperature is 38.5 degrees or higher; (2) Peripheral blood white blood cell count > 12*10^9/L; (3) C-reactive protein or PCT index increased, exceeding the upper limit of reference value; (4) Positive bacterial blood cultures or other evidence of infection; (5) Sign a informed consent.

Exclusion criteria

Exclusion criteria: 1. Known or suspected allergies to nitroimidazoles or cephalosporins; 2. Infection is caused by a fungus, parasite, virus, or tuberculosis; 3. Patients with severe peripheral and central nervous system diseases; 4. History of epilepsy; 5. Serious chronic liver disease child-pugh grade C; 6. Serum creatinine concentration =176.8µmol/L; 7. Hematopoietic function is low; 8. Chronic alcoholism; 9. The results of bacterial drug sensitivity indicated that cefoperazone resistance; 10. Pregnant and lactating women; 11. Other researchers considered the patients not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Clinical cure rate;	—

Secondary

Measure	Time frame
damage in other organs; image in inflammation absorption; types of surgery; AE;	—

Countries

China

Contacts

Public ContactMeng-Tao Zhou

The First Affiliated Hospital of Wenzhou Medical University

zmt0417@hotmail.com+86 13806697558

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026