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Pharmacokinetics of contizolamide in patients with acute pancreatitis complicated by Gram-positive bacterial infection

Pharmacokinetics of contizolamide in patients with acute pancreatitis complicated by Gram-positive bacterial infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071006
Enrollment
Unknown
Registered
2023-04-28
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

acute pancreatitis complicated by Gram-positive bacterial infection

Interventions

None:Contizolamide tablets are taken orally at 800mg (2 tablets) every 12 hours* 7or 14 days

Sponsors

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1: Age =18 and less than or equal to 70 2: Patients were diagnosed with acute pancreatitis according to Chinese Guidelines for Diagnosis and Treatment of Acute Pancreatitis (2021). The diagnostic criteria for acute pancreatitis include the following 3 criteria: (1) persistent pain in the upper abdomen 3: (2) serum amylase and/or lipase concentrations were 3 times higher than the normal upper limit 4: (3) Abdominal imaging examination results showed imaging changes consistent with acute pancreatitis. Acute pancreatitis is diagnosed if two of the three criteria are met 5: Patients with pancreatic (peripancreatic) or extrapancreatic infections (such as biliary system, lung, urinary system, catheter associated infections) caused by clinical microbiology diagnosis or clinical suspicion of gram-positive bacteria 6: After percutaneous drainage, surgical video-assisted debridement or laparotomy, patients with abdominal or retroperitoneal effusion or peripancreatic exudation can be collected by drainage. And/or, cholecystostomy or choledochal drainage may be performed in patients for whom bile can be collected 7: Volunteer to participate in the study and sign the informed consent. If the subject is unable to read and sign the informed consent due to incapacity or other reasons, his/her guardian shall represent the informed process and sign the informed consent. If the subject does not have the ability to read the informed consent (such as illiterate subjects), a witness shall witness the informed process and sign the informed consent

Exclusion criteria

Exclusion criteria: 1: Allergic to oxazolidinones 2: Those who are not suitable for administration through nasal feeding/gastrointestinal nutrition tube, or with gastrointestinal diseases that seriously affect oral drug absorption 3: According to AGI classification, gastrointestinal function evaluation is grade IV 4: Prior to 3 months to participate in other clinical study patients 5: Participants considered unfit to participate in the study or to influence the evaluation of the end points for a variety of reasons, such as pregnant and lactating women, or men or women who were unable to use effective contraception during the study period or within 6 months of the end of the study

Design outcomes

Primary

MeasureTime frame
Clinical cure rate; bacterial clearance rate;

Countries

CHINA

Contacts

Public ContactYU HONG

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

blueyu000@hotmail.com+86 13605705907

Outcome results

None listed

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