The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Location status: Recruiting
Recruiting
NCT Number: NCT07612163
Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Rational use of β-lactams is closely associated with the clinical outcome of patients with infections. Serum concentration of β-lactams varies from different populations. The objective of this study is to describe the clinical outcome of cirrhotic patients with infection treated by β-lactams in China, regarding diagnosis, treatment and follow-up. It is a single-center, retro-prospective, observational study. Inclusion criteria are an age ≥ 18, liver cirrhosis, diagnosed as bacteria infection and serum concentration must be determined during therapy. Data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. A descriptive analysis will be performed.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
β-lactams
DrugParticipants receiving β-lactams were included.
Primary outcomes
-
Mortality
Time frame: January 2018-December 2026
30-day mortality and 90-day mortality
-
Serum concentrations
Time frame: January 2018-December 2026
Serum concentrations of β-lactams
Secondary outcomes
-
Proportion of patients reach clinical response at end of treatment
Time frame: January 2018-December 2026
By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12*10^9/L or less than 4*10^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms
-
Proportion of patients reach clinical response at day 4 of treatment
Time frame: January 2018-December 2026
By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12*10^9/L or less than 4*10^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms
-
Daily Sequential Organ Failure Assessment score change
Time frame: January 2018-December 2026
Sequential Organ Failure Assessment score (Range from 0-24), lower score means a better outcome. Increase of 2 points within 48 hours means the presence of sepsis.
-
Incidence of Septic Shock
Time frame: January 2018-December 2026
Incidence of Septic Shock
-
Safety outcome measures
Time frame: January 2018-December 2026
Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of β-lactams
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Registry information
Official study title
Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- May 28, 2026
- Registry last updated
- May 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Prediction of Multidrug-resistant Bacterial Infection in Patients with Cirrhosis
NCT05641025
Bacterial Infections, Bacterial Infections and Mycoses
Buenos Aires, Argentina
View Trial Details
Recruiting
Large Algorithm Setting and Validation Study
NCT07607470
Bacterial Infections, Bacterial Infections and Mycoses
North Miami, Florida, United States
View Trial Details
Recruiting
First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients
NCT07708116
Bacterial Infections, Bacterial Infections and Mycoses
Groningen, Netherlands
View Trial Details
Recruiting
Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
NCT05783661
Bacterial Infections, Bacterial Infections and Mycoses
Barcelona, Spain
View Trial Details