Antibiotic ToxicityTACTILENCT05960006
A Study to Determine Pharmacokinetic Changes of Ceftriaxone in Patients With Liver Cirrhosis
An observational study of Antibiotic Toxicity and Liver Cirrhosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The investigators designed an observational multicenter explorative in vivo study to investigate the changes in ceftriaxone pharmacokinetics in blood and ascites. The investigators will include a total of 20 patients with liver cirrhosis admitted to the ward of participating hospitals. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Antibiotic Toxicity, Liver Cirrhosis, Renal Insufficiency
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jul 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Adult, Older adult
Study population: All admitted patients with the diagnosis of liver cirrhosis and ascites who receive at least a single dose of ceftriaxone during the current admission and receive diagnostic and/or therapeutic paracentesis following administration of ceftriaxone are suitable for inclusion in this study. The indication for diagnostic and/or therapeutic paracentesis is made upon the discretion of the treating physician following standard-of-care protocols.
Who may be able to join
- Age ≥18 years
- Clinical, radiological and/or histological diagnosis of liver cirrhosis and portal hypertension
- Presence of ascites
- Receiving ceftriaxone in the context of prophylaxis or treatment of infection
- Indication for diagnostic and/or therapeutic paracentesis
- Providing oral informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam university medical centers location AMC
Amsterdam, 1105AZ
About this study
Official title: An Observational Explorative Study to Determine Pharmacokinetic Changes of Ceftriaxone in Blood and Ascites in Patients Admitted With Decompensated Liver Cirrhosis With or Without Renal Impairment.
The investigators designed an observational multicenter explorative in vivo study to investigate the changes in ceftriaxone pharmacokinetics in blood and ascites. The investigators will include a total of 20 patients with liver cirrhosis admitted to the ward of participating hospitals. Patients are eligible when receiving ceftriaxone and concomitantly receive paracentesis. The investigators will collect all available waste blood samples of each participant, starting from study entry up until 48 hours after the last dosing interval of ceftriaxone. The investigators will collect all available waste ascites samples of each participant up until 48 hours after the last dosing interval of ceftriaxone. Duration of the trial: The study duration is variable and depends on the duration of ceftriaxone treatment and duration of hospital admission, which both are determined by the treating physician and is not influenced by study participation. Patients will be eligible for study inclusion when patients received (a single dose of) ceftriaxone treatment and undergo paracentesis during ceftriaxone treatment. The study will end 48 hours after the last dosing interval of ceftriaxone or until hospital discharge, whichever comes first. Study timeline: The investigators expect to enrol 1-2 participants every month. The total enrolment time will thus be approximately 12 months.
Read the detailed description
Objective: The primary objective is to determine the changes in ceftriaxone pharmacokinetics in blood and ascites in patients with decompensated liver cirrhosis to guide ceftriaxone dosing in these patients.
Study design: Observational explorative multicentre study
Study population: Adults (>18 years) with decompensated liver cirrhosis with the presence of ascites admitted to the clinical ward of participating centres who receive ceftriaxone and concomitantly undergo paracentesis during active antibiotic treatment.
Intervention: No intervention, the investigators will only collect the available waste blood and ascites samples.
Main study parameters/endpoints:
- Clearance (CL) of unbound ceftriaxone
- Volume of distribution (VD) of unbound ceftriaxone
- Penetration rate of unbound ceftriaxone from blood to ascites
- Elimination rate of unbound ceftriaxone from ascites by paracentesis
Secondary study parameters are:
- Target attainment of ceftriaxone in blood, defined as the unbound plasma concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC).
- Target attainment of ceftriaxone in ascites, defined as the unbound ascites concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC).
- Explorative analysis on the effects of liver disease severity (Child Pugh, MELD-score) and renal insufficiency (CKD-stage) on individual pharmacokinetic parameters
- Conditions
- Antibiotic Toxicity, Liver Cirrhosis, Renal Insufficiency, Ceftriaxone Overdose, Ascites Hepatic, Infection, Bacterial
- Being tested
- No intervention (observational study)
- Medical subject headings
- Liver Cirrhosis, Renal Insufficiency, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
There are no risks associated with participation because only waste material (blood and ascites) will be used for analysis and no additional blood collection or paracentesis will be performed in addition to standard-of-care. Moreover, hospital admittance and discharge, indication for interventional procedures, indication/initiation/duration/dosing of ceftriaxone, indication/timing/frequency of blood withdrawal for standard of care biochemical analysis and microbiological culturing as the indication, timing, frequency and duration of paracentesis are all decided by the treating physician independent of participation in the study. There are no extra site visits nor extra days of hospital admission. There is no direct benefit for participants of this explorative study. .
| Study group | Role | What they receive |
|---|---|---|
| observational ceftriaxone | Patiënts with liver cirrhosis receiving ceftriaxone treatment. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (CL) of unbound ceftriaxone
Clearance (CL) of unbound ceftriaxone
Measured: 12 months
Volume of distribution (VD) of unbound ceftriaxone
Volume of distribution (VD) of unbound ceftriaxone
Measured: 12 months
Penetration rate of unbound ceftriaxone from blood to ascites
Penetration rate of unbound ceftriaxone from blood to ascites
Measured: 12 months
Elimination rate of unbound ceftriaxone from ascites by paracentesis
Elimination rate of unbound ceftriaxone from ascites by paracentesis
Measured: 12 months
Secondary outcomes (5)
Target attainment of ceftriaxone in blood, defined as the unbound plasma concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)
Target attainment of ceftriaxone in blood, defined as the unbound plasma concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)
Measured: 12 months
Target attainment of ceftriaxone in ascites, defined as the unbound ascites concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)
Target attainment of ceftriaxone in ascites, defined as the unbound ascites concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)
Measured: 12 months
Explorative analysis on the effect of Child Pugh-score on individual pharmacokinetic parameters
Child Pugh score ranges from 5 points (minimum value) to 15 points (maximum value). Higher score means a worse outcome. Child Pugh score is a measure to determine the prognosis of patients with cirrhosis.
Measured: 12 months
Explorative analysis on the effect of MELD-score on individual pharmacokinetic parameters
MELD-score (Model for End-Stage Liver Disease, version: original, pre-2016) ranges from 6 points (minimum value) to 40 points (maximum value). Higher score means a worse outcome. MELD-score quantifies end-stage liver disease for transplant planning.
Measured: 12 months
Explorative analysis on the effect of CKD-stage on individual pharmacokinetic parameters
CKD (chronic kidney disease) stage ranges from stage 1 (minimum value) to stage 5 (maximum value). Higher score means a worse outcome. CKD-stage is based on the estimated glomerular filtration rate (eGFR, in mL/min/1.73m2) and refers to a measure of kidney function.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start10 Jul 2023
- Primary completion10 Apr 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ToxicityStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, Marten A Lantinga, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960006
- Sponsor's protocol ID
- W23_012 # 23.033
- Acronym
- TACTILE
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data is available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Explorative Study to Determine Pharmacokinetic Changes of Ceftriaxone in Blood and Ascites in Patients Admitted With Decompensated Liver Cirrhosis With or Without Renal Impairment.
- ClinicalTrials.gov ID
- NCT05960006
- Acronym / sponsor ID
- TACTILE / W23_012 # 23.033
- Conditions
- Antibiotic Toxicity, Liver Cirrhosis, Renal Insufficiency, Ceftriaxone Overdose, Ascites Hepatic, Infection, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 25 Jul 2023 (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.
The investigators designed an observational multicenter explorative in vivo study to investigate the changes in ceftriaxone pharmacokinetics in blood and ascites. The investigators will include a total of 20 patients with liver cirrhosis admitted to the ward of participating hospitals. Patients are eligible when receiving ceftriaxone and concomitantly receive paracentesis. The investigators will collect all available waste blood samples of each participant, starting from study entry up until 48 hours after the last dosing interval of ceftriaxone. The investigators will collect all available waste ascites samples of each participant up until 48 hours after the last dosing interval of ceftriaxone. Duration of the trial: The study duration is variable and depends on the duration of ceftriaxone treatment and duration of hospital admission, which both are determined by the treating physician and is not influenced by study participation. Patients will be eligible for study inclusion when patients received (a single dose of) ceftriaxone treatment and undergo paracentesis during ceftriaxone treatment. The study will end 48 hours after the last dosing interval of ceftriaxone or until hospital discharge, whichever comes first. Study timeline: The investigators expect to enrol 1-2 participants every month. The total enrolment time will thus be approximately 12 months.
Detailed description
Objective: The primary objective is to determine the changes in ceftriaxone pharmacokinetics in blood and ascites in patients with decompensated liver cirrhosis to guide ceftriaxone dosing in these patients.
Study design: Observational explorative multicentre study
Study population: Adults (>18 years) with decompensated liver cirrhosis with the presence of ascites admitted to the clinical ward of participating centres who receive ceftriaxone and concomitantly undergo paracentesis during active antibiotic treatment.
Intervention: No intervention, the investigators will only collect the available waste blood and ascites samples.
Main study parameters/endpoints:
- Clearance (CL) of unbound ceftriaxone
- Volume of distribution (VD) of unbound ceftriaxone
- Penetration rate of unbound ceftriaxone from blood to ascites
- Elimination rate of unbound ceftriaxone from ascites by paracentesis
Secondary study parameters are:
- Target attainment of ceftriaxone in blood, defined as the unbound plasma concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC).
- Target attainment of ceftriaxone in ascites, defined as the unbound ascites concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC).
- Explorative analysis on the effects of liver disease severity (Child Pugh, MELD-score) and renal insufficiency (CKD-stage) on individual pharmacokinetic parameters
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational ceftriaxone | – | Other: No intervention (observational study)Patiënts with liver cirrhosis receiving ceftriaxone treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All admitted patients with the diagnosis of liver cirrhosis and ascites who receive at least a single dose of ceftriaxone during the current admission and receive diagnostic and/or therapeutic paracentesis following administration of ceftriaxone are suitable for inclusion in this study. The indication for diagnostic and/or therapeutic paracentesis is made upon the discretion of the treating physician following standard-of-care protocols.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Clinical, radiological and/or histological diagnosis of liver cirrhosis and portal hypertension
- Presence of ascites
- Receiving ceftriaxone in the context of prophylaxis or treatment of infection
- Indication for diagnostic and/or therapeutic paracentesis
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No intervention (observational study)There are no risks associated with participation because only waste material (blood and ascites) will be used for analysis and no additional blood collection or paracentesis will be performed in addition to standard-of-care. Moreover, hospital admittance and discharge, indication for interventional procedures, indication/initiation/duration/dosing of ceftriaxone, indication/timing/frequency of blood withdrawal for standard of care biochemical analysis and microbiological culturing as the indication, timing, frequency and duration of paracentesis are all decided by the treating physician independent of participation in the study. There are no extra site visits nor extra days of hospital admission. There is no direct benefit for participants of this explorative study. . | Other | observational ceftriaxone |
Primary outcome
Clearance (CL) of unbound ceftriaxone
Time frame: 12 months
Clearance (CL) of unbound ceftriaxone
Volume of distribution (VD) of unbound ceftriaxone
Time frame: 12 months
Volume of distribution (VD) of unbound ceftriaxone
Penetration rate of unbound ceftriaxone from blood to ascites
Time frame: 12 months
Penetration rate of unbound ceftriaxone from blood to ascites
Elimination rate of unbound ceftriaxone from ascites by paracentesis
Time frame: 12 months
Elimination rate of unbound ceftriaxone from ascites by paracentesis
5 secondary outcomes
Target attainment of ceftriaxone in blood, defined as the unbound plasma concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)
Time frame: 12 months
Target attainment of ceftriaxone in ascites, defined as the unbound ascites concentration of ceftriaxone above at least one time the minimal inhibitory concentration (MIC) for 50% of the dosing interval (50%fT > 1MIC)
Time frame: 12 months
Explorative analysis on the effect of Child Pugh-score on individual pharmacokinetic parameters
Time frame: 12 months
Explorative analysis on the effect of MELD-score on individual pharmacokinetic parameters
Time frame: 12 months
Explorative analysis on the effect of CKD-stage on individual pharmacokinetic parameters
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data is available upon reasonable request.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Antibiotic Toxicity and Liver Cirrhosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 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: finished, as of the sponsor's last update on 8 Jan 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance (CL) of unbound ceftriaxone (time frame: 12 months). The study lists 4 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 8 Jan 2026.