Spontaneous Bacterial PeritonitisNCT07923318
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
A study testing Routine Follow-up Paracentesis at 48 Hours and Other in people with Spontaneous Bacterial Peritonitis and Paracentesis, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
Spontaneous bacterial peritonitis (SBP) is a serious infection that occurs in patients with liver cirrhosis and ascites and is associated with substantial morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis, Paracentesis, Treatment Efficacy
- What is being tested?
- Routine Follow-up Paracentesis at 48 Hours and Other
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Adults aged 18 years or older
- Diagnosis of liver cirrhosis based on clinical, histologic, or imaging findings
- Diagnosis of spontaneous bacterial peritonitis confirmed by an ascitic fluid polymorphonuclear leukocyte (PMN) count of ≥250 cells/mm³ at initial paracentesis
- Ability and willingness to provide written informed consent
Who cannot join
- Suspected secondary bacterial peritonitis, including suspected perforation of a gastrointestinal organ
- Inability to safely undergo paracentesis, defined as platelet count <20,000/mm³ or prothrombin time international normalized ratio (PT-INR) >3.0
- Active bleeding or shock
- Expected survival of less than 48 hours
- Pregnancy or breastfeeding
- Previous ascitic fluid or blood culture demonstrating resistance to cefotaxime or ceftriaxone
- Any other condition that, in the investigator's judgment, would prevent adherence to the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chonnam National University Hospital
Gwangju, Gwangju, 61469
Jae Hyun Yoon, Assistant Professor, M.D., Ph.D., +82-62-220-6216, zenmake14@gmail.com
About this study
Official title: Randomized Controlled Study of Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis in Liver Cirrhosis: A Pilot Study
Spontaneous bacterial peritonitis (SBP) is a serious infection that occurs in patients with liver cirrhosis and ascites and is associated with substantial morbidity and mortality. Current clinical practice often includes follow-up paracentesis approximately 48 hours after starting antibiotic treatment to assess the change in the ascitic fluid polymorphonuclear leukocyte (PMN) count. However, it remains uncertain whether routine follow-up paracentesis improves clinical outcomes compared with a strategy based primarily on clinical response.
This pilot randomized controlled trial will evaluate whether routine follow-up paracentesis is necessary in patients with cirrhosis and SBP. A total of 40 adult patients with SBP will be randomly assigned in a 1:1 ratio to either a routine follow-up paracentesis group or a no-routine follow-up paracentesis group. All participants will receive standard antibiotic therapy and intravenous albumin according to the study protocol.
Read more
Participants assigned to the routine follow-up paracentesis group will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy. Ascitic fluid PMN counts and other laboratory findings will be assessed, and antibiotic treatment may be modified according to the treatment response. Participants assigned to the no-routine follow-up paracentesis group will be monitored using clinical symptoms, vital signs, and blood inflammatory markers without scheduled repeat paracentesis. However, paracentesis may be performed at any time if clinically indicated, such as in the presence of worsening abdominal symptoms, persistent fever, or hemodynamic instability.
The study will compare clinical outcomes between the two treatment strategies, including 30-day and 90-day survival, treatment response, duration of antibiotic therapy, length of hospital stay, SBP recurrence, complications, new infections, and medical costs. The results of this pilot study are intended to provide preliminary evidence for determining whether routine follow-up paracentesis can be safely avoided in selected patients with SBP and to inform the design of a larger randomized controlled trial.
- Conditions
- Spontaneous Bacterial Peritonitis, Paracentesis, Treatment Efficacy, Adverse Events, Survival Rate
- Being tested
- Routine Follow-up Paracentesis at 48 Hours, Other
- Keywords
- Liver cirrhosis, Paracentesis, Ascites, Spontaneous bacterial peritonitis
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Follow-up Paracentesis at 48 HoursProcedure or surgery
Participants assigned to the routine follow-up paracentesis arm will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy for spontaneous bacterial peritonitis. Ascitic fluid will be analyzed for polymorphonuclear leukocyte (PMN) count, bacterial culture and antimicrobial susceptibility, and biochemical parameters. If the ascitic fluid PMN count has not decreased by at least 25% from baseline, antibiotic therapy may be escalated according to the study protocol. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol.
OtherProcedure or surgery
Participants will not undergo scheduled follow-up paracentesis at approximately 48 hours. Treatment response will be assessed based on clinical symptoms, vital signs, and blood inflammatory markers. Paracentesis may be performed if clinically indicated, such as for worsening abdominal symptoms, persistent fever, or hemodynamic instability. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| A (Routine Follow-up Paracentesis) | Experimental | Routine follow-up paracentesis approximately 48 hours after initiation of antibiotic therapy. Receives: Procedure: Routine Follow-up Paracentesis at 48 Hours |
| B (No Routine Follow-up Paracentesis) | Active comparator | No routine follow-up paracentesis; paracentesis will be performed only when clinically indicated. Receives: Procedure: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 Day Overall Survival
The proportion of participants who are alive at 30 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge.
Measured: 30 days after randomization
90 Day Overall Survival
The proportion of participants who are alive at 90 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge.
Measured: 90 days after randomization
Secondary outcomes (7)
Length of Hospital Stay
Total number of days from hospital admission to discharge.
Measured: From hospital admission to discharge, assessed up to 90 days
Antibiotic-Related Adverse Events
The proportion of participants experiencing antibiotic-related adverse events, including Clostridioides difficile-associated diarrhea, drug allergy, or anaphylaxis.
Measured: Through index hospital discharge, assessed up to 90 days
Duration of Antibiotic Therapy
Total number of days of systemic antibiotic treatment administered for spontaneous bacterial peritonitis during the index hospitalization.
Measured: From initiation of antibiotic therapy to discontinuation or hospital discharge, assessed up to 90 days
Recurrence of Spontaneous Bacterial Peritonitis
The proportion of participants who develop recurrent spontaneous bacterial peritonitis within 90 days after randomization.
Measured: Up to 90 days after randomization
New Infection During Hospitalization
The proportion of participants who develop a new infection other than the initial episode of spontaneous bacterial peritonitis during the index hospitalization.
Measured: Through index hospital discharge, assessed up to 90 days
Cirrhosis-Related Complications
The proportion of participants who develop major cirrhosis-related complications, including hepatorenal syndrome or clinically significant bleeding, during follow-up.
Measured: Up to 90 days after randomization
Medical Costs
Total medical costs incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care.
Measured: Total direct medical costs (in Korean Won or USD) incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care, as assessed from hospital billing records.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start4 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean association for study of the liver
- Responsible party
- Principal investigator, Jae Hyun Yoon, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923318
- Sponsor's protocol ID
- CNUH-2026-313
- Status last verified
- Sep 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data collected during the study, including data dictionaries, will be shared upon reasonable request directed to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis in Liver Cirrhosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT07923318
- Acronym / sponsor ID
- CNUH-2026-313
- Conditions
- Spontaneous Bacterial Peritonitis, Paracentesis, Treatment Efficacy, Adverse Events, Survival Rate
- Keywords
- Liver cirrhosis, Paracentesis, Ascites, Spontaneous bacterial peritonitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Korean association for study of the liver
- Study start
- 4 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Nov 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.
Spontaneous bacterial peritonitis (SBP) is a serious infection that occurs in patients with liver cirrhosis and ascites and is associated with substantial morbidity and mortality. Current clinical practice often includes follow-up paracentesis approximately 48 hours after starting antibiotic treatment to assess the change in the ascitic fluid polymorphonuclear leukocyte (PMN) count. However, it remains uncertain whether routine follow-up paracentesis improves clinical outcomes compared with a strategy based primarily on clinical response.
This pilot randomized controlled trial will evaluate whether routine follow-up paracentesis is necessary in patients with cirrhosis and SBP. A total of 40 adult patients with SBP will be randomly assigned in a 1:1 ratio to either a routine follow-up paracentesis group or a no-routine follow-up paracentesis group. All participants will receive standard antibiotic therapy and intravenous albumin according to the study protocol.
Participants assigned to the routine follow-up paracentesis group will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy. Ascitic fluid PMN counts and other laboratory findings will be assessed, and antibiotic treatment may be modified according to the treatment response. Participants assigned to the no-routine follow-up paracentesis group will be monitored using clinical symptoms, vital signs, and blood inflammatory markers without scheduled repeat paracentesis. However, paracentesis may be performed at any time if clinically indicated, such as in the presence of worsening abdominal symptoms, persistent fever, or hemodynamic instability.
The study will compare clinical outcomes between the two treatment strategies, including 30-day and 90-day survival, treatment response, duration of antibiotic therapy, length of hospital stay, SBP recurrence, complications, new infections, and medical costs. The results of this pilot study are intended to provide preliminary evidence for determining whether routine follow-up paracentesis can be safely avoided in selected patients with SBP and to inform the design of a larger randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (Routine Follow-up Paracentesis) | Experimental | Procedure: Routine Follow-up Paracentesis at 48 HoursRoutine follow-up paracentesis approximately 48 hours after initiation of antibiotic therapy. |
| B (No Routine Follow-up Paracentesis) | Active comparator | Procedure: OtherNo routine follow-up paracentesis; paracentesis will be performed only when clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Diagnosis of liver cirrhosis based on clinical, histologic, or imaging findings
- Diagnosis of spontaneous bacterial peritonitis confirmed by an ascitic fluid polymorphonuclear leukocyte (PMN) count of ≥250 cells/mm³ at initial paracentesis
- Ability and willingness to provide written informed consent
Key exclusion criteria (7 listed)
- Suspected secondary bacterial peritonitis, including suspected perforation of a gastrointestinal organ
- Inability to safely undergo paracentesis, defined as platelet count <20,000/mm³ or prothrombin time international normalized ratio (PT-INR) >3.0
- Active bleeding or shock
- Expected survival of less than 48 hours
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Routine Follow-up Paracentesis at 48 HoursParticipants assigned to the routine follow-up paracentesis arm will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy for spontaneous bacterial peritonitis. Ascitic fluid will be analyzed for polymorphonuclear leukocyte (PMN) count, bacterial culture and antimicrobial susceptibility, and biochemical parameters. If the ascitic fluid PMN count has not decreased by at least 25% from baseline, antibiotic therapy may be escalated according to the study protocol. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol. | Procedure or surgery | A (Routine Follow-up Paracentesis) |
| OtherParticipants will not undergo scheduled follow-up paracentesis at approximately 48 hours. Treatment response will be assessed based on clinical symptoms, vital signs, and blood inflammatory markers. Paracentesis may be performed if clinically indicated, such as for worsening abdominal symptoms, persistent fever, or hemodynamic instability. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol. | Procedure or surgery | B (No Routine Follow-up Paracentesis) |
Primary outcome
30 Day Overall Survival
Time frame: 30 days after randomization
The proportion of participants who are alive at 30 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge.
90 Day Overall Survival
Time frame: 90 days after randomization
The proportion of participants who are alive at 90 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge.
7 secondary outcomes
Length of Hospital Stay
Time frame: From hospital admission to discharge, assessed up to 90 days
Antibiotic-Related Adverse Events
Time frame: Through index hospital discharge, assessed up to 90 days
Duration of Antibiotic Therapy
Time frame: From initiation of antibiotic therapy to discontinuation or hospital discharge, assessed up to 90 days
Recurrence of Spontaneous Bacterial Peritonitis
Time frame: Up to 90 days after randomization
New Infection During Hospitalization
Time frame: Through index hospital discharge, assessed up to 90 days
Cirrhosis-Related Complications
Time frame: Up to 90 days after randomization
Medical Costs
Time frame: Total direct medical costs (in Korean Won or USD) incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care, as assessed from hospital billing records.
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 6 Nov 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data collected during the study, including data dictionaries, will be shared upon reasonable request directed to the principal investigator.
Related trials for Spontaneous Bacterial Peritonitis
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Cirrhosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Follow-up Paracentesis at 48 Hours and Other in people with Spontaneous Bacterial Peritonitis and Paracentesis, run by Chonnam National University Hospital at 1 site in South Korea.
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 4 inclusion and 7 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 6 Nov 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 South Korea. 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 Eun-chae Yoo, CRC(Clinical research coordinator) (+82-62-220-6216, karenaec5@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Day Overall Survival (time frame: 30 days after randomization). 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 6 Nov 2026.