SBPPhase 4NCT01265173
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC
A Phase 4 study testing Cefotaxime, Ceftriaxone and Ciprofloxacin in people with SBP and Liver Cirrhosis, run by Korea University at 2 sites in South Korea.
Trial summary
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- SBP, Liver Cirrhosis
- What is being tested?
- Cefotaxime, Ceftriaxone and Ciprofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2007to Jun 2018
- Phase
- Phase 4
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Liver cirrhosis patients with ascites
- Ascitic fluid PMN cell count >250/mm3
- Age: 16~70 years old
Who cannot join
- Allergic to 3rd generation cephalosporin or quinolone
- Antibiotics within 2 weeks
- Open abdominal surgery within 4 weeks
- Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
- HCC with portal vein thrombosis
- Pregnant woman
- HIV positive
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Korea University Ansan Hospital
Ansan
Korea University Anam Hospital
Seoul, 136705
About this study
Official title: Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.
Read the detailed description
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.
- Conditions
- SBP, Liver Cirrhosis
- Being tested
- Cefotaxime, Ceftriaxone, Ciprofloxacin
- Keywords
- SBP, liver cirrhosis, antibiotics
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefotaximeDrug
3 g
CeftriaxoneDrug
2 g
CiprofloxacinDrug
400 mg
| Study group | Role | What they receive |
|---|---|---|
| Cefotaxime | Active comparator | iv 2G q 8hrs for general, dose titration if needed (eg.CKD) Receives: Drug: Cefotaxime |
| Ceftriaxone | Experimental | iv 2G q 24hrs Receives: Drug: Ceftriaxone |
| Ciprofloxacine | Experimental | iv 400mg q 12hrs for general, dose titration if needed (eg.CKD) Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection resolution rates within 5 days of treatment
PMN < 250/mm3 from ascitic fluid
Measured: 5 days (120 hours)
Secondary outcomes (1)
Mortality & recurrence rates within 1 month
Mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startApr 2007
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SBPStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Ho Um, Korea University
- Investigators
- Soon Ho Um, Professor, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265173
- Sponsor's protocol ID
- CCCCSBP
- Status last verified
- Apr 2020
- First submitted
- 22 Dec 2010
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yim HJ, Kim TH, Suh SJ, Yim SY, Jung YK, Seo YS, Kang SH, Kim MY, Baik SK, Kim HS, Kim YS, Park SY, Kim BI, Park JY, Heo J, Sohn JH, Heo NY, Han KH, Um SH. Response-Guided Therapy With Cefotaxime, Ceftriaxone, or Ciprofloxacin for Spontaneous Bacterial Peritonitis: A Randomized Trial: A Validation Study of 2021 AASLD Practice Guidance for SBP. Am J Gastroenterol. 2023 Apr 1;118(4):654-663. doi: 10.14309/ajg.0000000000002126. Epub 2023 Jan 3.
PubMed 36594820
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01265173
- Acronym / sponsor ID
- CCCCSBP
- Conditions
- SBP, Liver Cirrhosis
- Keywords
- SBP, liver cirrhosis, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 Dec 2010 (estimated)
- 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 one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.
Detailed description
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cefotaxime | Active comparator | Drug: Cefotaximeiv 2G q 8hrs for general, dose titration if needed (eg.CKD) |
| Ceftriaxone | Experimental | Drug: Ceftriaxoneiv 2G q 24hrs |
| Ciprofloxacine | Experimental | Drug: Ciprofloxaciniv 400mg q 12hrs for general, dose titration if needed (eg.CKD) |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Liver cirrhosis patients with ascites
- Ascitic fluid PMN cell count >250/mm3
- Age: 16~70 years old
Key exclusion criteria (7 listed)
- Allergic to 3rd generation cephalosporin or quinolone
- Antibiotics within 2 weeks
- Open abdominal surgery within 4 weeks
- Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
- HCC with portal vein thrombosis
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 |
|---|---|---|
| Cefotaxime3 g | Drug | Cefotaxime |
| Ceftriaxone2 g | Drug | Ceftriaxone |
| Ciprofloxacin400 mg | Drug | Ciprofloxacine |
Primary outcome
Infection resolution rates within 5 days of treatment
Time frame: 5 days (120 hours)
PMN < 250/mm3 from ascitic fluid
1 secondary outcome
Mortality & recurrence rates within 1 month
Time frame: 1 month
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 6 Apr 2020.
- Derived from this study: PubMed 36594820Yim HJ, Kim TH, Suh SJ, Yim SY, Jung YK, Seo YS, Kang SH, Kim MY, Baik SK, Kim HS, Kim YS, Park SY, Kim BI, Park JY, Heo J, Sohn JH, Heo NY, Han KH, Um SH. Response-Guided Therapy With Cefotaxime, Ceftriaxone, or Ciprofloxacin for Spontaneous Bacterial Peritonitis: A Randomized Trial: A Validation Study of 2021 AASLD Practice Guidance for SBP. Am J Gastroenterol. 2023 Apr 1;118(4):654-663. doi: 10.14309/ajg.0000000000002126. Epub 2023 Jan 3.
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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. This study is not recruiting at the moment.
Soon Ho Um, Professor principal investigator
Korea University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefotaxime, Ceftriaxone and Ciprofloxacin in people with SBP and Liver Cirrhosis, run by Korea University at 2 sites 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 3 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: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Infection resolution rates within 5 days of treatment (time frame: 5 days (120 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265173, which also lists 1 linked publication.
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 Apr 2020.