Cirrhosis, LiverPhase 3NCT03695705
Rifaximin and Norfloxacin for Prevention of SBP in Adults With Decompensated Cirrhosis
A Phase 3 study testing Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day in people with Cirrhosis, Liver, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
Spontaneous bacterial peritonitis (SBP) is a frequent and severe complication of cirrhotic patients with ascites.Early diagnosis and prompt treatment with effective antibiotics significantly improves the prognosis of this complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 2017
- 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
- Low Ascitic fluid protein level <1gm/dl
- Advanced liver disease as evidenced by CTP≥9
- Serum billirubin≥3 mg/dl
- Impaired renal function defined by serum creatinine≥1.2 mg/dl
- Blood urea nitrogen 25mg/dl
- Serum sodium level≤ 1.2 meq/l
Who cannot join
- Inability to obtain informed consent from patient or relatives.
- Acute on chronic liver failure
- Severe cardiopulmonary disease
- Pregnancy
- Age <18yrs
- Post liver transplant patients
Show all 15Show fewer
- HIV infection
- Recent abdominal surgery(with in last 6 months)
- Portal vein thrombosis
- Splenectomy
- Patient on immunosuppressive drugs except for alcoholic steatohepatitis
- Patients on psychoactive drugs, such as antidepressants or sedatives
- Hypersensitivity to norfloxacin and rifaximin
- Malignancies including Hepatocellular carcinoma
- Prior history of hepatic encephalopathy on Rifaximin -
About this study
Official title: Randomized Control Trial of Rifaximin and Norfloxacin in Primary and Secondary Prophylaxis of Spontaneous Bacterial Peritonitis(SBP) in Cirrhotic Patients
Spontaneous bacterial peritonitis (SBP) is a frequent and severe complication of cirrhotic patients with ascites.Early diagnosis and prompt treatment with effective antibiotics significantly improves the prognosis of this complication. The recommended treatment is a third generation cephalosporin given intravenously for five days.Following recovery patients should receive secondary prophylaxis with a quinolone such as oral norfloxacin 400 mg/day.Also all patients should be assessed for liver transplantation.
Most commonly used antibiotic for both primary and secondary prophylaxis is norfloxacin 400 mg once daily.Other antibiotics like cotrimoxazole,ceftriaxone,ciprofloxacin and rifaximin have also been evaluated in various studies.Use of antibiotic prophylaxis has been evaluated to decrease recurrence of SBP in treated groups than in control groups.
Read more
Rifaximin is an oral antimicrobial agent with broad-spectrum activity that is gut-selective and nonsystemic. Rifaximin appears to have a low level of selection for resistant bacterial mutants. Intestinal decontamination is known to increase peripheral blood counts by suppressing endotoxemia and inhibiting the effects of cytokines and nitric oxide on blood counts.
With this mechanisms rifaximin has been already proven to decrease recurrence of hepatic encephalopathy.The most important mechanism for development of SBP is bacterial translocation (BT).Translocation of enteric flora occurs via defective mucosal barrier.BT is considered the key step in pathogenesis of SBP and cirrhotic patients.It is also the critical factor that is responsible for host immune response and secreation of inflammatory mediators that is responsible for hemodynamic changes in cirrhotics.Three most important mechanism of bacterial translocation include bacterial overgrowth,physical disruption of gut mucosal barrier and impaired host defence.
Rifaximin by mechanism of gut decontamination may reduce translocation of intestinal bacteria into mesenteric lymph nodes then into ascitic fluid.Thus it may prove useful in preventing recurrence of SBP.There was no study till date that has compared efficacy of Norfloxacin and rifaximin to prevent development of SBP.This pilot study was done to compare the efficacy of rifaximin with norfloxacin in both primary and secondary prophylaxis of SBP in a prospective randomized open-label and non-inferiority trial
Read the detailed description
Ascites is the most common complication of cirrhosis, and 60% of patients with compensated cirrhosis develop ascites within 10 years during the course of their disease . Ascites occurs only when portal hypertension has developed and is related to inability to excrete an adequate amount of sodium into urine, leading to a positive sodium balance.Evidence suggests that renal sodium retention in patients with cirrhosis is secondary to arterial splanchnic vasodilation. This causes a decrease in effective arterial blood volume with activation of arterial and cardiopulmonary volume receptors, and homeostatic activation of vasoconstrictor and sodium-retaining systems (i.e., the sympathetic nervous system and the (renin-angiotensin-aldosterone system). Renal sodium retention leads to expansion of the extracellular fluid volume and formation of ascites and edema . The development of ascites is associated with a poor prognosis and impaired quality of life in patients with cirrhosis . Thus, patients with ascites should generally be considered for referral for liver transplantation. There is a clear rationale for the management of ascites in patients with cirrhosis, as a successful treatment may improve the outcome and symptoms.
Spontaneous bacterial peritonitis (SBP) is a frequent and severe complication of cirrhotic patients with ascites.Early diagnosis and prompt treatment with effective antibiotics significantly improves the prognosis of this complication. The recommended treatment is a third generation cephalosporin given intravenously for five days. The most commonly used is cefotaxime, up to 4 g/day in 2-4 divided doses because of its proven efficacy and safety3. Repeat diagnostic paracentesis to document response by a greater than 25% decrease in ascitic fluid neutrophil count at 48 hours after commencement of antibiotic is recommended. With this regimen, recovery from SBP is higher than 80-90% and 30-day survival is at least 80%.Following recovery patients should receive secondary prophylaxis with a quinolone such as oral norfloxacin 400 mg/day.Also all patients should be assessed for liver transplantation
.Most commonly used antibiotic for both primary and secondary prophylaxis is norfloxacin 400 mg once daily.Other antibiotics like cotrimoxazole,ceftriaxone,ciprofloxacin and rifaximin have also been evaluated in various studies.Use of antibiotic prophylaxis has been evaluated to decrease recurrence of SBP in treated groups than in control groups.
Rifaximin is an oral antimicrobial agent with broad-spectrum activity that is gut-selective and nonsystemic. Rifaximin appears to have a low level of selection for resistant bacterial mutants and may not confer the same risks as those associated with systemic antibiotics. A study in patients with alcohol-related decompensated cirrhosis reported that rifaximin treatment reduced endotoxin levels and resulted in significantly decreased hepatic venous pressure gradient values, which decreased the occurrence of complications in advanced liver disease.13Intestinal decontamination with rifaximin has been shown to increase platelet count significantly in thrombocytopenic patients with cirrhosis.This benefit is thought to be achieved through a concomitant reduction of endotoxemia.Improvements in platelet counts in patients with thrombocytopenia could decrease bleeding risks and complications of medical procedures, and help stabilize underlying liver disease. Intestinal decontamination is also known to increase peripheral blood counts by suppressing endotoxemia and inhibiting the effects of cytokines and nitric oxide on blood counts.
With this mechanisms rifaximin has been already proven to decrease recurrence of hepatic encephalopathy.The most important mechanism for development of SBP is bacterial translocation (BT) which refers to entry of bacteria or their products into regional lymph nodes,systemic circulation and extraintestinal organs.Translocation of enteric flora occurs via defective mucosal barrier.BT is considered the key step in pathogenesis of SBP and cirrhotic patients.It is also the critical factor that is responsible for host immune response and secreation of inflammatory mediators that is responsible for hemodynamic changes in cirrhotics.Three most important mechanism of bacterial translocation include bacterial overgrowth,physical disruption of gut mucosal barrier and impaired host defence.
Rifaximin by mechanism of gut decontamination may reduce translocation of intestinal bacteria into mesenteric lymph nodes then into ascitic fluid.Thus it may prove useful in preventing recurrence of SBP.There is no study till date that has compared efficacy of Norfloxacin and rifaximin to prevent development of SBP.This pilot study was done to compare the efficacy of rifaximin with norfloxacin in both primary and secondary prophylaxis of SBP in a prospective randomized open-label and non-inferiority trial
- Conditions
- Cirrhosis, Liver
- Being tested
- Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day
- Keywords
- Norfloxacin,Rifaximin,Prophylaxis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a dayDrug
Patients on Rifaximin prophylaxis will be given 550 mg twice daily and on Norfloxacin prophylaxis will receive Norfloxacin 400 mg once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Primary prophylaxis arm | Other | 28 Patients with decompensated cirrhosis without past history of SBP were randomised to receive Rifaximin at dose 550 mg twice daily.29 Patients with decompensated cirrhosis without past history of SBP were randomized to receive Norfloxacin at dose 400 mg once daily Receives: Drug: Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day |
| Secondary prophylaxis arm | Other | 26 Patients with decompensated cirrhosis with past history of SBP were randomized to receive Rifaximin at dose 550 mg twice daily.33 Patients with decompensated cirrhosis with past history of SBP were randomized to receive Norfloxacin at dose 400 mg once daily Receives: Drug: Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence SBP in patients on Rifaximin prophylaxis compared to Norfloxacin
Incidence of development of SBP in patients with(Secondary prophylaxis) or without(Primary prophylaxis) in patients on Rifaximin compared to norfloxacin
Measured: 6 months
Secondary outcomes (3)
Incidence of hepatic encephalopathy
Incidence of development of hepatic encephalopathy in patients on Rifaximin prophylaxis compared to Norfloxacin prophylaxis
Measured: 6 months
Incidence of overall mortality
Incidence of mortality in patients on Rifaximin prophylaxis compared to Norfloxacin prophylaxis
Measured: 6 months
Incidence of development of sepsis
Incidence of development of sepsis in patients on Rifaximin prophylaxis compared to Norfloxacin prophylaxis
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 posted4 Oct 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radha K Dhiman, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- RADHA K DHIMAN, DM,FRCP, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695705
- Sponsor's protocol ID
- PGIMER
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zacharias 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 37467180Praharaj DL, Premkumar M, Roy A, Verma N, Taneja S, Duseja A, Dhiman RK. Rifaximin Vs. Norfloxacin for Spontaneous Bacterial Peritonitis Prophylaxis: A Randomized Controlled Trial. J Clin Exp Hepatol. 2022 Mar-Apr;12(2):336-342. doi: 10.1016/j.jceh.2021.08.010. Epub 2021 Aug 18.
PubMed 35535057
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Rifaximin and Norfloxacin in Primary and Secondary Prophylaxis of Spontaneous Bacterial Peritonitis(SBP) in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT03695705
- Acronym / sponsor ID
- PGIMER
- Conditions
- Cirrhosis, Liver
- Keywords
- Norfloxacin,Rifaximin,Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 4 Oct 2018 (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 frequent and severe complication of cirrhotic patients with ascites.Early diagnosis and prompt treatment with effective antibiotics significantly improves the prognosis of this complication. The recommended treatment is a third generation cephalosporin given intravenously for five days.Following recovery patients should receive secondary prophylaxis with a quinolone such as oral norfloxacin 400 mg/day.Also all patients should be assessed for liver transplantation.
Most commonly used antibiotic for both primary and secondary prophylaxis is norfloxacin 400 mg once daily.Other antibiotics like cotrimoxazole,ceftriaxone,ciprofloxacin and rifaximin have also been evaluated in various studies.Use of antibiotic prophylaxis has been evaluated to decrease recurrence of SBP in treated groups than in control groups.
Rifaximin is an oral antimicrobial agent with broad-spectrum activity that is gut-selective and nonsystemic. Rifaximin appears to have a low level of selection for resistant bacterial mutants. Intestinal decontamination is known to increase peripheral blood counts by suppressing endotoxemia and inhibiting the effects of cytokines and nitric oxide on blood counts.
With this mechanisms rifaximin has been already proven to decrease recurrence of hepatic encephalopathy.The most important mechanism for development of SBP is bacterial translocation (BT).Translocation of enteric flora occurs via defective mucosal barrier.BT is considered the key step in pathogenesis of SBP and cirrhotic patients.It is also the critical factor that is responsible for host immune response and secreation of inflammatory mediators that is responsible for hemodynamic changes in cirrhotics.Three most important mechanism of bacterial translocation include bacterial overgrowth,physical disruption of gut mucosal barrier and impaired host defence.
Rifaximin by mechanism of gut decontamination may reduce translocation of intestinal bacteria into mesenteric lymph nodes then into ascitic fluid.Thus it may prove useful in preventing recurrence of SBP.There was no study till date that has compared efficacy of Norfloxacin and rifaximin to prevent development of SBP.This pilot study was done to compare the efficacy of rifaximin with norfloxacin in both primary and secondary prophylaxis of SBP in a prospective randomized open-label and non-inferiority trial
Detailed description
Ascites is the most common complication of cirrhosis, and 60% of patients with compensated cirrhosis develop ascites within 10 years during the course of their disease . Ascites occurs only when portal hypertension has developed and is related to inability to excrete an adequate amount of sodium into urine, leading to a positive sodium balance.Evidence suggests that renal sodium retention in patients with cirrhosis is secondary to arterial splanchnic vasodilation. This causes a decrease in effective arterial blood volume with activation of arterial and cardiopulmonary volume receptors, and homeostatic activation of vasoconstrictor and sodium-retaining systems (i.e., the sympathetic nervous system and the (renin-angiotensin-aldosterone system). Renal sodium retention leads to expansion of the extracellular fluid volume and formation of ascites and edema . The development of ascites is associated with a poor prognosis and impaired quality of life in patients with cirrhosis . Thus, patients with ascites should generally be considered for referral for liver transplantation. There is a clear rationale for the management of ascites in patients with cirrhosis, as a successful treatment may improve the outcome and symptoms.
Spontaneous bacterial peritonitis (SBP) is a frequent and severe complication of cirrhotic patients with ascites.Early diagnosis and prompt treatment with effective antibiotics significantly improves the prognosis of this complication. The recommended treatment is a third generation cephalosporin given intravenously for five days. The most commonly used is cefotaxime, up to 4 g/day in 2-4 divided doses because of its proven efficacy and safety3. Repeat diagnostic paracentesis to document response by a greater than 25% decrease in ascitic fluid neutrophil count at 48 hours after commencement of antibiotic is recommended. With this regimen, recovery from SBP is higher than 80-90% and 30-day survival is at least 80%.Following recovery patients should receive secondary prophylaxis with a quinolone such as oral norfloxacin 400 mg/day.Also all patients should be assessed for liver transplantation
.Most commonly used antibiotic for both primary and secondary prophylaxis is norfloxacin 400 mg once daily.Other antibiotics like cotrimoxazole,ceftriaxone,ciprofloxacin and rifaximin have also been evaluated in various studies.Use of antibiotic prophylaxis has been evaluated to decrease recurrence of SBP in treated groups than in control groups.
Rifaximin is an oral antimicrobial agent with broad-spectrum activity that is gut-selective and nonsystemic. Rifaximin appears to have a low level of selection for resistant bacterial mutants and may not confer the same risks as those associated with systemic antibiotics. A study in patients with alcohol-related decompensated cirrhosis reported that rifaximin treatment reduced endotoxin levels and resulted in significantly decreased hepatic venous pressure gradient values, which decreased the occurrence of complications in advanced liver disease.13Intestinal decontamination with rifaximin has been shown to increase platelet count significantly in thrombocytopenic patients with cirrhosis.This benefit is thought to be achieved through a concomitant reduction of endotoxemia.Improvements in platelet counts in patients with thrombocytopenia could decrease bleeding risks and complications of medical procedures, and help stabilize underlying liver disease. Intestinal decontamination is also known to increase peripheral blood counts by suppressing endotoxemia and inhibiting the effects of cytokines and nitric oxide on blood counts.
With this mechanisms rifaximin has been already proven to decrease recurrence of hepatic encephalopathy.The most important mechanism for development of SBP is bacterial translocation (BT) which refers to entry of bacteria or their products into regional lymph nodes,systemic circulation and extraintestinal organs.Translocation of enteric flora occurs via defective mucosal barrier.BT is considered the key step in pathogenesis of SBP and cirrhotic patients.It is also the critical factor that is responsible for host immune response and secreation of inflammatory mediators that is responsible for hemodynamic changes in cirrhotics.Three most important mechanism of bacterial translocation include bacterial overgrowth,physical disruption of gut mucosal barrier and impaired host defence.
Rifaximin by mechanism of gut decontamination may reduce translocation of intestinal bacteria into mesenteric lymph nodes then into ascitic fluid.Thus it may prove useful in preventing recurrence of SBP.There is no study till date that has compared efficacy of Norfloxacin and rifaximin to prevent development of SBP.This pilot study was done to compare the efficacy of rifaximin with norfloxacin in both primary and secondary prophylaxis of SBP in a prospective randomized open-label and non-inferiority trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary prophylaxis arm | Other | Drug: Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day28 Patients with decompensated cirrhosis without past history of SBP were randomised to receive Rifaximin at dose 550 mg twice daily.29 Patients with decompensated cirrhosis without past history of SBP were randomized to receive Norfloxacin at dose 400 mg once daily |
| Secondary prophylaxis arm | Other | Drug: Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day26 Patients with decompensated cirrhosis with past history of SBP were randomized to receive Rifaximin at dose 550 mg twice daily.33 Patients with decompensated cirrhosis with past history of SBP were randomized to receive Norfloxacin at dose 400 mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Low Ascitic fluid protein level <1gm/dl
- Advanced liver disease as evidenced by CTP≥9
- Serum billirubin≥3 mg/dl
- Impaired renal function defined by serum creatinine≥1.2 mg/dl
- Blood urea nitrogen 25mg/dl
Key exclusion criteria (15 listed)
- Inability to obtain informed consent from patient or relatives.
- Acute on chronic liver failure
- Severe cardiopulmonary disease
- Pregnancy
- Age <18yrs
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 |
|---|---|---|
| Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a dayPatients on Rifaximin prophylaxis will be given 550 mg twice daily and on Norfloxacin prophylaxis will receive Norfloxacin 400 mg once daily for 6 months | Drug | Primary prophylaxis arm, Secondary prophylaxis arm |
Primary outcome
Incidence SBP in patients on Rifaximin prophylaxis compared to Norfloxacin
Time frame: 6 months
Incidence of development of SBP in patients with(Secondary prophylaxis) or without(Primary prophylaxis) in patients on Rifaximin compared to norfloxacin
3 secondary outcomes
Incidence of hepatic encephalopathy
Time frame: 6 months
Incidence of overall mortality
Time frame: 6 months
Incidence of development of sepsis
Time frame: 6 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 4 Oct 2018.
- 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.
- Derived from this study: PubMed 35535057Praharaj DL, Premkumar M, Roy A, Verma N, Taneja S, Duseja A, Dhiman RK. Rifaximin Vs. Norfloxacin for Spontaneous Bacterial Peritonitis Prophylaxis: A Randomized Controlled Trial. J Clin Exp Hepatol. 2022 Mar-Apr;12(2):336-342. doi: 10.1016/j.jceh.2021.08.010. Epub 2021 Aug 18.
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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.
RADHA K DHIMAN, DM,FRCP principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day in people with Cirrhosis, Liver, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 15 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 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Incidence SBP in patients on Rifaximin prophylaxis compared to Norfloxacin (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 NCT03695705, which also lists 2 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 4 Oct 2018.