NCT07612163 Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients
| NCT ID | NCT07612163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Bacterial Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-12-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-12-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients may benefit from the personalized β-lactams dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review, prospective observe and analyze the clinical outcomes of patients with liver cirrhosis, and to build a population pharmacokinetics model in the population mentioned above.
Eligibility Criteria
Inclusion Criteria: Age over 18 years Chinese patient: male or female Liver cirrhosis Diagnosed as bacterial infection Treated by β-lactams Serum concentration determined during therapy Exclusion Criteria: Duration of β-lactams treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of β-lactams
Contact & Investigator
Dayu Chen
PRINCIPAL INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Frequently Asked Questions
Who can join the NCT07612163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bacterial Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07612163 currently recruiting?
Yes, NCT07612163 is actively recruiting participants. Contact the research team at cdy_pharmacy@njglyy.com for enrollment information.
Where is the NCT07612163 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07612163 clinical trial?
NCT07612163 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Dayu Chen at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 1,000 participants.