Spontaneous Bacterial PeritonitisPhase 3NCT04159870
Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis
A Phase 3 study testing Rifaximin and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Ospedali Riuniti di Foggia at 1 site in Italy.
Trial summary
Background Prophylaxis of SBP is indicated in three high-risk populations: patients with acute gastrointestinal hemorrhage, patients with low total protein content in ascitic fluid, and patients with a previous history of SBP (secondary prophylaxis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Rifaximin and Norfloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteItaly
- Study dates
- 5 Nov 2019to 20 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 mEq/L)
Who cannot join
- Age under 18 years
- Previous history of SBP
- Previous use of antibiotics within the previous two weeks
- Previous GIT bleeding within one month
- Resolving ascites for one month after diuretic therapy
- Liver malignancy, organic renal disease
Show all 9Show fewer
- Human immunodeficiency virus infection
- Known hypersensitivity to planned drugs
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rifaximin Versus Norfloxacin in the Primary Prophylaxis of Spontaneous Bacterial Peritonitis
Background
Prophylaxis of SBP is indicated in three high-risk populations: patients with acute gastrointestinal hemorrhage, patients with low total protein content in ascitic fluid, and patients with a previous history of SBP (secondary prophylaxis).
Read more
Selective intestinal decontamination with norfloxacin, a quinolone with relatively poor gastrointestinal absorption and with antibacterial activity against GNB, is the most commonly used regimen, but several concerns have been recently raised in this regard.
A recent network meta-analysis published by the investigators showed that rifaximin determines interesting results in this setting but needs to be tested in further trials.
Given its favorable safety profile and the relatively low cost, rifaximin could represent the antibiotic of choice in long-term prophylaxis.
Study Objective To establish the prophylactic efficacy, of rifaximin as compared to norfloxacin in cirrhotic patients with low protein content in the ascitic fluid.
Protocol design Phase III, two-arms, open-label, multi-center, randomized controlled trial.
Trial population Patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 milliequivalent [mEq]/L)
Protocol Treatments
- The Treatment arm will undergo rifaximin 1200 mg/day in 3 doses.
- The Control arm will undergo norfloxacin 400 mg 1/die for 6 months
Primary Endpoint Prevention of spontaneous bacterial peritonitis episodes.
Secondary Endpoints
- Prevention of mortality (both all-cause and liver-related mortality)
- Preventions of hepatorenal syndrome
- Prevention of other infections
- Adverse events
Sample size and study duration It will be planned to enroll 322 patients (161 per arms) within 18 months. A minimum follow up of 6 months from the last patient recruited will be required.
Read the detailed description
Background
Spontaneous bacterial peritonitis (SBP) is a commonly observed and severe complication in patients with cirrhosis and ascites, with a reported prevalence ranging from 10% to 25% in hospitalized cirrhotic patients1.
Given the high mortality rate and the risk of developing hepato-renal syndrome (HRS), prophylaxis of SBP is indicated particularly in three high-risk populations: patients with acute gastrointestinal hemorrhage, patients with low total protein content in ascitic fluid, and patients with a previous history of SBP (secondary prophylaxis)2.
The ideal prophylactic agent should be safe, affordable, and effective particularly against anaerobic bacteria translocating from the gut as most episodes of SBP are thought to result from the translocation of enteric Gram-negative bacilli (GNB)3.
Selective intestinal decontamination with norfloxacin, a quinolone with relatively poor gastrointestinal absorption and with antibacterial activity against GNB, is the most commonly used regimen4, but several concerns have been recently raised in this regard. In fact, the epidemiology of bacterial infections in cirrhosis is evolving with an increasing incidence of infections caused by quinolone-resistant bacteria5; moreover, primary prophylaxis in low-protein ascitic patients requires long-term antibiotic regimens (whose exact duration is still matter of debate), hence less expensive and better tolerated agents such as rifaximin have been tested with conflicting results6.
A recent network meta-analysis published by the investigators showed that rifaximin determines interesting results in this setting but needs to be tested in further trials7.
Given its favorable safety profile and the relatively low cost, rifaximin could represent the antibiotic of choice in long-term prophylaxis.
Study Objective To establish the prophylactic efficacy, of rifaximin as compared to norfloxacin in cirrhotic patients with low protein content in the ascitic fluid.
Protocol design Phase III, two-arms, open-label, multi-center, randomized controlled trial.
Trial population Patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 mEq/L)
Protocol Treatments
- The Treatment arm will undergo rifaximin 1200 mg/day in 3 doses.
- The Control arm will undergo norfloxacin 400 mg 1/die for 6 months
Protocol
Baseline evaluation will include history and physical examination, liver and renal tests, ascitic fluid analysis and culture, fresh urine sediment, and abdominal ultrasonography. Treatment will start immediately after randomization. Follow-up visits will be performed every 4 weeks. Treatment compliance will be assessed by interviewing the patient and by tablet count at each visit. A patient will be considered noncompliant when the study medication will not be taken for 7 days or more, or will fail to take more than 20 % of their pills or miss two or more visits.
Medications will be interrupted when patients develop an episode of SBP (ascitic fluid neutrophil count[ 250 cell/ml with or without clinical evidence), or have upper gastrointestinal (GIT) bleeding or receive a liver transplant.
Diagnostic paracentesis will be performed when clinically indicated. Diagnosis of spontaneous bacteremia, SBP, urinary infection, and other infections will be made by biological fluid cultures and analysis; type-1 and type-2 HRS will be diagnosed according to the criteria of the International Ascites Club. Spontaneous bacteremia and SBP will be treated with ceftriaxone.
Primary Endpoint Prevention of spontaneous bacterial peritonitis episodes.
Secondary Endpoints
- Prevention of mortality (both all-cause and liver-related mortality)
- Preventions of hepatorenal syndrome
- Prevention of other infections
- Adverse events
Sample size and study duration It will be planned to enroll 322 patients (161 per arms) within 18 months. A minimum follow up of 6 months from the last patient recruited will be required.
Treatment strategy Patients complying with the eligibility criteria will be randomized in a 1:1 fashion to receive rifaximin 1200 mg/day or norfloxacin 400 mg/day. No cross-over will be allowed.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Rifaximin, Norfloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Rifaximin pills 400 mg x 3/day
NorfloxacinDrug
Norlfloxacin 400 mg 1 pill/day
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Rifaximin 1200 mg/day in 3 doses Receives: Drug: Rifaximin |
| Control Group | Active comparator | Norfloxacin 400 mg/day in one dose Receives: Drug: Norfloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Spontaneous Bacterial Peritonitis
Rate of episodes of spontaneous bacterial peritonitis
Measured: 6 months
Secondary outcomes (4)
Prevention of mortality
Rate of deaths observed
Measured: 6 months
Prevention of hepatorenal syndrome
Rate of hepatorenal syndrome episodes
Measured: 6 months
Prevention of other infections
Rate of other infections
Measured: 6 months
Adverse Events
Rate of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start5 Nov 2019
- Primary completion20 Nov 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedali Riuniti di Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Facciorusso, Ospedali Riuniti di Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159870
- Sponsor's protocol ID
- RIFA01
- Status last verified
- Feb 2021
- First submitted
- 7 Nov 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez J, Navasa M, Gomez J, Colmenero J, Vila J, Arroyo V, Rodes J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8. doi: 10.1053/jhep.2002.30082.
PubMed 11786970European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.
PubMed 20633946Piano S, Brocca A, Mareso S, Angeli P. Infections complicating cirrhosis. Liver Int. 2018 Feb;38 Suppl 1:126-133. doi: 10.1111/liv.13645.
PubMed 29427501Soriano G, Guarner C, Tomas A, Villanueva C, Torras X, Gonzalez D, Sainz S, Anguera A, Cusso X, Balanzo J, et al. Norfloxacin prevents bacterial infection in cirrhotics with gastrointestinal hemorrhage. Gastroenterology. 1992 Oct;103(4):1267-72. doi: 10.1016/0016-5085(92)91514-5.
PubMed 1397884Aparicio JR, Such J, Pascual S, Arroyo A, Plazas J, Girona E, Gutierrez A, de Vera F, Palazon JM, Carnicer F, Perez-Mateo M. Development of quinolone-resistant strains of Escherichia coli in stools of patients with cirrhosis undergoing norfloxacin prophylaxis: clinical consequences. J Hepatol. 1999 Aug;31(2):277-83. doi: 10.1016/s0168-8278(99)80225-6.
PubMed 10453941Menshawy A, Mattar O, Barssoum K, AboEl-Naga AM, Salim HM, Mohamed AMF, Elgebaly A, Abd-Elsalam S. Safety and Efficacy of Rifaximin in Prophylaxis of Spontaneous Bacterial Peritonitis: A Systematic Review and Meta-analysis. Curr Drug Targets. 2019;20(4):380-387. doi: 10.2174/1389450119666180924145156.
PubMed 30246636Facciorusso A, Papagiouvanni I, Cela M, Buccino VR, Sacco R. Comparative efficacy of long-term antibiotic treatments in the primary prophylaxis of spontaneous bacterial peritonitis. Liver Int. 2019 Aug;39(8):1448-1458. doi: 10.1111/liv.14109. Epub 2019 Apr 25.
PubMed 30920712Goel A, Rahim U, Nguyen LH, Stave C, Nguyen MH. Systematic review with meta-analysis: rifaximin for the prophylaxis of spontaneous bacterial peritonitis. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1029-1036. doi: 10.1111/apt.14361. Epub 2017 Oct 9.
PubMed 28994123Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
PubMed 37467180
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin Versus Norfloxacin in the Primary Prophylaxis of Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT04159870
- Acronym / sponsor ID
- RIFA01
- Conditions
- Spontaneous Bacterial Peritonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Ospedali Riuniti di FoggiaUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 12 Nov 2019 (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.
Background
Prophylaxis of SBP is indicated in three high-risk populations: patients with acute gastrointestinal hemorrhage, patients with low total protein content in ascitic fluid, and patients with a previous history of SBP (secondary prophylaxis).
Selective intestinal decontamination with norfloxacin, a quinolone with relatively poor gastrointestinal absorption and with antibacterial activity against GNB, is the most commonly used regimen, but several concerns have been recently raised in this regard.
A recent network meta-analysis published by the investigators showed that rifaximin determines interesting results in this setting but needs to be tested in further trials.
Given its favorable safety profile and the relatively low cost, rifaximin could represent the antibiotic of choice in long-term prophylaxis.
Study Objective To establish the prophylactic efficacy, of rifaximin as compared to norfloxacin in cirrhotic patients with low protein content in the ascitic fluid.
Protocol design Phase III, two-arms, open-label, multi-center, randomized controlled trial.
Trial population Patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 milliequivalent [mEq]/L)
Protocol Treatments
- The Treatment arm will undergo rifaximin 1200 mg/day in 3 doses.
- The Control arm will undergo norfloxacin 400 mg 1/die for 6 months
Primary Endpoint Prevention of spontaneous bacterial peritonitis episodes.
Secondary Endpoints
- Prevention of mortality (both all-cause and liver-related mortality)
- Preventions of hepatorenal syndrome
- Prevention of other infections
- Adverse events
Sample size and study duration It will be planned to enroll 322 patients (161 per arms) within 18 months. A minimum follow up of 6 months from the last patient recruited will be required.
Detailed description
Background
Spontaneous bacterial peritonitis (SBP) is a commonly observed and severe complication in patients with cirrhosis and ascites, with a reported prevalence ranging from 10% to 25% in hospitalized cirrhotic patients1.
Given the high mortality rate and the risk of developing hepato-renal syndrome (HRS), prophylaxis of SBP is indicated particularly in three high-risk populations: patients with acute gastrointestinal hemorrhage, patients with low total protein content in ascitic fluid, and patients with a previous history of SBP (secondary prophylaxis)2.
The ideal prophylactic agent should be safe, affordable, and effective particularly against anaerobic bacteria translocating from the gut as most episodes of SBP are thought to result from the translocation of enteric Gram-negative bacilli (GNB)3.
Selective intestinal decontamination with norfloxacin, a quinolone with relatively poor gastrointestinal absorption and with antibacterial activity against GNB, is the most commonly used regimen4, but several concerns have been recently raised in this regard. In fact, the epidemiology of bacterial infections in cirrhosis is evolving with an increasing incidence of infections caused by quinolone-resistant bacteria5; moreover, primary prophylaxis in low-protein ascitic patients requires long-term antibiotic regimens (whose exact duration is still matter of debate), hence less expensive and better tolerated agents such as rifaximin have been tested with conflicting results6.
A recent network meta-analysis published by the investigators showed that rifaximin determines interesting results in this setting but needs to be tested in further trials7.
Given its favorable safety profile and the relatively low cost, rifaximin could represent the antibiotic of choice in long-term prophylaxis.
Study Objective To establish the prophylactic efficacy, of rifaximin as compared to norfloxacin in cirrhotic patients with low protein content in the ascitic fluid.
Protocol design Phase III, two-arms, open-label, multi-center, randomized controlled trial.
Trial population Patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 mEq/L)
Protocol Treatments
- The Treatment arm will undergo rifaximin 1200 mg/day in 3 doses.
- The Control arm will undergo norfloxacin 400 mg 1/die for 6 months
Protocol
Baseline evaluation will include history and physical examination, liver and renal tests, ascitic fluid analysis and culture, fresh urine sediment, and abdominal ultrasonography. Treatment will start immediately after randomization. Follow-up visits will be performed every 4 weeks. Treatment compliance will be assessed by interviewing the patient and by tablet count at each visit. A patient will be considered noncompliant when the study medication will not be taken for 7 days or more, or will fail to take more than 20 % of their pills or miss two or more visits.
Medications will be interrupted when patients develop an episode of SBP (ascitic fluid neutrophil count[ 250 cell/ml with or without clinical evidence), or have upper gastrointestinal (GIT) bleeding or receive a liver transplant.
Diagnostic paracentesis will be performed when clinically indicated. Diagnosis of spontaneous bacteremia, SBP, urinary infection, and other infections will be made by biological fluid cultures and analysis; type-1 and type-2 HRS will be diagnosed according to the criteria of the International Ascites Club. Spontaneous bacteremia and SBP will be treated with ceftriaxone.
Primary Endpoint Prevention of spontaneous bacterial peritonitis episodes.
Secondary Endpoints
- Prevention of mortality (both all-cause and liver-related mortality)
- Preventions of hepatorenal syndrome
- Prevention of other infections
- Adverse events
Sample size and study duration It will be planned to enroll 322 patients (161 per arms) within 18 months. A minimum follow up of 6 months from the last patient recruited will be required.
Treatment strategy Patients complying with the eligibility criteria will be randomized in a 1:1 fashion to receive rifaximin 1200 mg/day or norfloxacin 400 mg/day. No cross-over will be allowed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: RifaximinRifaximin 1200 mg/day in 3 doses |
| Control Group | Active comparator | Drug: NorfloxacinNorfloxacin 400 mg/day in one dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 mEq/L)
Key exclusion criteria (9 listed)
- Age under 18 years
- Previous history of SBP
- Previous use of antibiotics within the previous two weeks
- Previous GIT bleeding within one month
- Resolving ascites for one month after diuretic therapy
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 |
|---|---|---|
| RifaximinRifaximin pills 400 mg x 3/day | Drug | Intervention Group |
| NorfloxacinNorlfloxacin 400 mg 1 pill/day | Drug | Control Group |
Primary outcome
Prevention of Spontaneous Bacterial Peritonitis
Time frame: 6 months
Rate of episodes of spontaneous bacterial peritonitis
4 secondary outcomes
Prevention of mortality
Time frame: 6 months
Prevention of hepatorenal syndrome
Time frame: 6 months
Prevention of other infections
Time frame: 6 months
Adverse Events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Results publication: PubMed 11786970Fernandez J, Navasa M, Gomez J, Colmenero J, Vila J, Arroyo V, Rodes J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8. doi: 10.1053/jhep.2002.30082.
- Results publication: PubMed 20633946European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.
- Results publication: PubMed 29427501Piano S, Brocca A, Mareso S, Angeli P. Infections complicating cirrhosis. Liver Int. 2018 Feb;38 Suppl 1:126-133. doi: 10.1111/liv.13645.
- Results publication: PubMed 1397884Soriano G, Guarner C, Tomas A, Villanueva C, Torras X, Gonzalez D, Sainz S, Anguera A, Cusso X, Balanzo J, et al. Norfloxacin prevents bacterial infection in cirrhotics with gastrointestinal hemorrhage. Gastroenterology. 1992 Oct;103(4):1267-72. doi: 10.1016/0016-5085(92)91514-5.
- Results publication: PubMed 10453941Aparicio JR, Such J, Pascual S, Arroyo A, Plazas J, Girona E, Gutierrez A, de Vera F, Palazon JM, Carnicer F, Perez-Mateo M. Development of quinolone-resistant strains of Escherichia coli in stools of patients with cirrhosis undergoing norfloxacin prophylaxis: clinical consequences. J Hepatol. 1999 Aug;31(2):277-83. doi: 10.1016/s0168-8278(99)80225-6.
- Results publication: PubMed 30246636Menshawy A, Mattar O, Barssoum K, AboEl-Naga AM, Salim HM, Mohamed AMF, Elgebaly A, Abd-Elsalam S. Safety and Efficacy of Rifaximin in Prophylaxis of Spontaneous Bacterial Peritonitis: A Systematic Review and Meta-analysis. Curr Drug Targets. 2019;20(4):380-387. doi: 10.2174/1389450119666180924145156.
- Results publication: PubMed 30920712Facciorusso A, Papagiouvanni I, Cela M, Buccino VR, Sacco R. Comparative efficacy of long-term antibiotic treatments in the primary prophylaxis of spontaneous bacterial peritonitis. Liver Int. 2019 Aug;39(8):1448-1458. doi: 10.1111/liv.14109. Epub 2019 Apr 25.
- Results publication: PubMed 28994123Goel A, Rahim U, Nguyen LH, Stave C, Nguyen MH. Systematic review with meta-analysis: rifaximin for the prophylaxis of spontaneous bacterial peritonitis. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1029-1036. doi: 10.1111/apt.14361. Epub 2017 Oct 9.
- Derived from this study: PubMed 37467180Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
- Individual participant dataSharing planned: No
Related trials for Spontaneous Bacterial Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Not yet recruitingPhase 4
Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
Cirrhosis With Spontaneous Bacterial Peritonitis
Not yet recruitingObservational study
Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.
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.
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?
A Phase 3 study testing Rifaximin and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Ospedali Riuniti di Foggia at 1 site in Italy.
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 9 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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 Italy. 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?
Results are not available in the source record.
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?
Prevention of Spontaneous Bacterial Peritonitis (time frame: 6 months). 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 NCT04159870, which also lists 9 linked publications.
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 16 Feb 2021.