Bacterial InfectionsNCT07612163
Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients
An observational study of Bacterial Infections, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- β-lactams
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese adult cirrhotic patients with bacterial infections treated by β-lactams
Who may be able to join
- Age over 18 years Chinese patient: male or female Liver cirrhosis Diagnosed as bacterial infection Treated by β-lactams Serum concentration determined during therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Dayu Chen, +862583106666, cdy_pharmacy@njglyy.com
About this study
Official title: Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Bacterial Infections
- Being tested
- β-lactams
- Keywords
- β-lactam, Bacterial Infections, Liver cirrhosis
- Medical subject headings
- Bacterial Infections, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-lactamsDrug
Participants receiving β-lactams were included.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic patients treated by β-lactams | Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by β-lactams Receives: Drug: β-lactams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
30-day mortality and 90-day mortality
Measured: January 2018-December 2026
Serum concentrations
Serum concentrations of β-lactams
Measured: January 2018-December 2026
Secondary outcomes (5)
Proportion of patients reach clinical response at end of treatment
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
Measured: January 2018-December 2026
Proportion of patients reach clinical response at day 4 of treatment
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
Measured: January 2018-December 2026
Daily Sequential Organ Failure Assessment score change
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.
Measured: January 2018-December 2026
Incidence of Septic Shock
Incidence of Septic Shock
Measured: January 2018-December 2026
Safety outcome measures
Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of β-lactams
Measured: January 2018-December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start31 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Dayu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Dayu Chen, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612163
- Sponsor's protocol ID
- 2023-298-02
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study
- ClinicalTrials.gov ID
- NCT07612163
- Acronym / sponsor ID
- 2023-298-02
- Conditions
- Bacterial Infections
- Keywords
- β-lactam, Bacterial Infections, Liver cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 May 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic patients treated by β-lactams | – | Drug: β-lactamsPatients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by β-lactams |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adult cirrhotic patients with bacterial infections treated by β-lactams
Key inclusion criteria (1 listed)
- Age over 18 years Chinese patient: male or female Liver cirrhosis Diagnosed as bacterial infection Treated by β-lactams Serum concentration determined during therapy
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| β-lactamsParticipants receiving β-lactams were included. | Drug | Cirrhotic patients treated by β-lactams |
Primary outcome
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
5 secondary outcomes
Proportion of patients reach clinical response at end of treatment
Time frame: January 2018-December 2026
Proportion of patients reach clinical response at day 4 of treatment
Time frame: January 2018-December 2026
Daily Sequential Organ Failure Assessment score change
Time frame: January 2018-December 2026
Incidence of Septic Shock
Time frame: January 2018-December 2026
Safety outcome measures
Time frame: January 2018-December 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Dayu Chen principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dayu Chen (+862583106666, cdy_pharmacy@njglyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: January 2018-December 2026). The study lists 2 primary outcomes in all. 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 28 May 2026.