Spontaneous Bacterial PeritonitisPhase 3NCT02011841
Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients
A Phase 3 study testing Rifaximin and Ciprofloxacin in people with Spontaneous Bacterial Peritonitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Rifaximin and Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with cirrhosis based on clinical, biochemical, ultrasonographic and/or histological criteria
- Patients who had recovered from an episode of spontaneous bacterial peritonitis
- Age > 18 and <80 years
Who cannot join
- Decompensated cirrhotic patients with
- serum bilirubin > 3.2 mg/dL
- prothrombin time < 25%
- serum creatinine > 3 mg/dL
- Active gastrointestinal bleeding
- Hepatic encephalopathy > grade 2
- Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients: A Prospective, Multicenter, Randomized, Open-label, Controlled Phase III Study
The aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.
Read the detailed description
- Rifaximin is an antibiotic with a broad-spectrum activity against gram-positive and gram-negative microorganisms, both aerobes and anaerobes within the gastrointestinal tract. The main advantage of rifaximin is that it is poorly absorbable, which minimizes the antimicrobial resistance and adverse events and renders the drug safe in all patient populations. In addition, rifaximin has a better activity against gram-positive organisms than norfloxacin.
- The appreciation of the potential role of enteric flora in the pathogenesis of several gastrointestinal diseases has broadened the clinical use of rifaximin, which is now used for hepatic encephalopathy, small intestine bacterial overgrowth, inflammatory bowel disease, and Clostridium difficile infection. Theoretically, by reducing the total number of the gut bacteria, rifaximin could also be used to achieve intestinal decontamination in patients with liver cirrhosis and ascites, thus preventing spontaneous bacterial peritonitis.
- A small retrospective study concluded that rifaximin suppresses intestinal bacterial overgrowth, bacterial translocation in cirrhotic patients with ascites with no history of previous spontaneous bacterial peritonitis episodes. Prospective clinical trials are warranted to evaluate the role of rifaximin for prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Rifaximin, Ciprofloxacin
- Keywords
- liver cirrhosis, ascites, spontaneous bacterial peritonitis, recurrence
- Medical subject headings
- Liver Cirrhosis, Ascites, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Normix
rifaximin 1200 mg/day orally for 6 months
CiprofloxacinDrug
ciprofloxacin 500 mg/day orally for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin group | Experimental | Rifaximin 1200 mg/day orally for 6 months Receives: Drug: Rifaximin |
| Control group | Active comparator | Ciprofloxacin 500 mg/day orally for 6 months Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of spontaneous bacterial peritonitis
The proportion of patients who recurred spontaneous bacterial peritonitis.
Measured: every 4 weeks, up to 24 weeks
Secondary outcomes (5)
mortality
All-cause mortality and cause-specific mortality (mortality due to spontaneous bacterial peritonitis)
Measured: up to 24 weeks
The recurrence of culture-negative spontaneous bacterial peritonitis
The proportion of patients who recurred culture-negative spontaneous bacterial peritonitis.
Measured: every 4 weeks, up to 24 weeks
Causative bacteria of recurrent spontaneous bacterial peritonitis
Causative bacteria of recurrent spontaneous bacterial peritonitis and susceptibility
Measured: every 4 weeks, up to 24 weeks
Change of gut microbiota
Gut microbiota will be analyzed at baseline and week 12
Measured: at baseline, week 12
Infections other than spontaneous bacterial peritonitis
Infections other than spontaneous bacterial peritonitis (i.e. urinary tract infection, respiratory tract infection, etc.)
Measured: every 4 weeks, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: We failed to recruit patients
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.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hoon Lee, Seoul National University Hospital
- Investigators
- Jeong-Hoon Lee, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011841
- Sponsor's protocol ID
- Rifaximin_SBP
- Status last verified
- Apr 2017
- First submitted
- 10 Dec 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients: A Prospective, Multicenter, Randomized, Open-label, Controlled Phase III Study
- ClinicalTrials.gov ID
- NCT02011841
- Acronym / sponsor ID
- Rifaximin_SBP
- Conditions
- Spontaneous Bacterial Peritonitis
- Keywords
- liver cirrhosis, ascites, spontaneous bacterial peritonitis, recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We failed to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Dec 2013 (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.
The aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.
Detailed description
- Rifaximin is an antibiotic with a broad-spectrum activity against gram-positive and gram-negative microorganisms, both aerobes and anaerobes within the gastrointestinal tract. The main advantage of rifaximin is that it is poorly absorbable, which minimizes the antimicrobial resistance and adverse events and renders the drug safe in all patient populations. In addition, rifaximin has a better activity against gram-positive organisms than norfloxacin.
- The appreciation of the potential role of enteric flora in the pathogenesis of several gastrointestinal diseases has broadened the clinical use of rifaximin, which is now used for hepatic encephalopathy, small intestine bacterial overgrowth, inflammatory bowel disease, and Clostridium difficile infection. Theoretically, by reducing the total number of the gut bacteria, rifaximin could also be used to achieve intestinal decontamination in patients with liver cirrhosis and ascites, thus preventing spontaneous bacterial peritonitis.
- A small retrospective study concluded that rifaximin suppresses intestinal bacterial overgrowth, bacterial translocation in cirrhotic patients with ascites with no history of previous spontaneous bacterial peritonitis episodes. Prospective clinical trials are warranted to evaluate the role of rifaximin for prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin group | Experimental | Drug: RifaximinRifaximin 1200 mg/day orally for 6 months |
| Control group | Active comparator | Drug: CiprofloxacinCiprofloxacin 500 mg/day orally for 6 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with cirrhosis based on clinical, biochemical, ultrasonographic and/or histological criteria
- Patients who had recovered from an episode of spontaneous bacterial peritonitis
- Age > 18 and <80 years
Key exclusion criteria (7 listed)
- Decompensated cirrhotic patients with
- Active gastrointestinal bleeding
- Hepatic encephalopathy > grade 2
- Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma
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 |
|---|---|---|
| RifaximinAlso: Normixrifaximin 1200 mg/day orally for 6 months | Drug | Rifaximin group |
| Ciprofloxacinciprofloxacin 500 mg/day orally for 6 months | Drug | Control group |
Primary outcome
The recurrence rate of spontaneous bacterial peritonitis
Time frame: every 4 weeks, up to 24 weeks
The proportion of patients who recurred spontaneous bacterial peritonitis.
5 secondary outcomes
mortality
Time frame: up to 24 weeks
The recurrence of culture-negative spontaneous bacterial peritonitis
Time frame: every 4 weeks, up to 24 weeks
Causative bacteria of recurrent spontaneous bacterial peritonitis
Time frame: every 4 weeks, up to 24 weeks
Change of gut microbiota
Time frame: at baseline, week 12
Infections other than spontaneous bacterial peritonitis
Time frame: every 4 weeks, up to 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Spontaneous Bacterial Peritonitis
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.
Jeong-Hoon Lee, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin and Ciprofloxacin in people with Spontaneous Bacterial Peritonitis, run by Seoul 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 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: withdrawn, as of the sponsor's last update on 25 Apr 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
The recurrence rate of spontaneous bacterial peritonitis (time frame: every 4 weeks, up to 24 weeks). 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 25 Apr 2017.