Spontaneous Bacterial PeritonitisNCT06199843
Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial)
A study testing Rifaximin and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
SBP is a common complication of cirrhotics with associated increased mortality. After first episode of SBP there is increased risk of again developing SBP, with increased chance of developing resistant organism. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- 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
- Age>18 years
- Cirrhosis (of any etiology) with ascites
- Prior incident SBP
Who cannot join
- Allergy to norfloxacin or rifaximin
- Recent history of upper gastrointestinal bleed (UGIB) within 2 weeks
- Patients with a history of multiple episodes of SBP
- Patients with inoperable or not treatable HCC or other non-hepatic malignancy
- Patients on immunosuppression
- HIV infected
Show all 11Show fewer
- Post liver transplant
- Recent (<6 months) abdominal surgery
- Pregnant/lactating women
- Other causes of ascites like tubercular or malignancy
- Patients developing SBP on Norfloxcacin
Trial locations and contacts
1 site in 1 country.
India1 site
Dr Jaya Benjamin
New Delhi, National Capital Territory of Delhi, 110070
Dr Jayshree Biswas, MD, 01146300000, jayashreeb790@gmail.com
About this study
Official title: Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial): a Randomized Control Trial
SBP is a common complication of cirrhotics with associated increased mortality. After first episode of SBP there is increased risk of again developing SBP, with increased chance of developing resistant organism. So after the first episode of SBP, prophylaxis for prevention of second episode onwards is mandatory and therefore Rifaximin or Norfloxacin is considered. It has been seen that apart from preventing SBP they have other benefits with negligible side effects and therefore it is to be seen what other benefits including mortality benefits these drugs can confer.
Read the detailed description
Hypothesis:-Rifaximin will be more effective in decreasing the incidence of SBP in patients with cirrhosis and prior episode of SBP
AIM:-.To study the efficacy and safety of Rifaximin vs Norfloxacin in preventing incident SBP, preventing non-SBP infections, and improving transplant free survival in patients with cirrhosis and previous episode of SBP
Methodology Single centered Open labeled Randomized Controlled Trial
Randomization will be done by block randomization method taking block size as 10. Data will be entered in Microsoft Excel and will be analysed by SPSS Version 28.Categorical Data will be represented as frequency (%) and will be analysed using Chi square or Fisher Exact Test as appropriate.Continuous Data will be represented as Mean +/- SD and compared using Student T test or Mann Whitney as per normality conditions are met or not.Beside this an appropriate analysis like survival analysis will be carried out at the time of Data Analysis.P value <0.05 will be considered as significant.
Rescue therapy: To be given to patients who develop SBP while on secondary prophylaxis, these patients will initially be treated by iv medication in hospital settings followed by change in therapy.
- Patients in Rifaximin limb developing SBP will switch to Norfloxacin
- Patients in Norfloxacin limb developing SBP will switch to Rifaximin
Treatment Failure: Defined as development of SBP at end of 6 months or 1 year of treatment.
Study population: age >18 years with prior incident SBP
Study design: Randomised case controlled trial
Study period: 1year after ethical clearance
Sample size: 280 (140 in each arm)
Intervention: This RCT will be conducted at ILBS New Delhi Monitoring and assessment: Monitoring will be done forall the parameters of the objective. Documentation will be done for any adverse effects which will happen.
STATISTICAL ANALYSIS: Assuming incidence of SBP over 6 months is 4% in Rifaximin \& 15% in Norfloxacin Alpha 5% and power 80%. Enrollment of 260 cases (130 in each arm). Assuming dropout rate 10%.Total study cases calculated as 280 (140 in each arm). Random allocation in each arm by block method taking 10 as block size
- 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 550 mg BD
NorfloxacinDrug
Norfloxacin 400 mg OD
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Rifaximin 550 mg BD Receives: Drug: Rifaximin |
| Norfloxacin | Active comparator | Norfloxacin 400 mg OD Receives: Drug: Norfloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrence of SBP within 6 months
Measured: 6 months
Secondary outcomes (15)
Incidence of recurrence of SBP within12 months
Measured: 12 months
Incidence of other site infections within 6 months
Measured: 6 months
Incidence of other site infections within 12 months
Measured: 12 months
to look for resistance pattern of infection in both norfloxacin and rifampicin group, type of resistant bacteria (MDR/XDR), and response of both groups to rifampicin and norfloxacin in secondary prophylaxis of SBP
Measured: 12 months
Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 6 months
Measured: 6 months
Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 12 months)
Measured: 12 months
Transplant free survival by 6 months
Measured: 6 months
Transplant free survival by 12 months
Measured: 12 months
Change in Child-Turcotte-Pugh (CTP) by 6 months
Measured: 6 months
Change in Model for End-Stage Liver Disease (MELD) scores by 6 months
Measured: 6 months
Change in Model for End-Stage Liver Disease Sodium (MELD Na) scores by 6 months
Measured: 6 months
Change in Child-Turcotte-Pugh (CTP) scores by 12 months
Measured: 12 months
Change in Model for End-Stage Liver Disease (MELD) scores by 12 months
Measured: 12 months
Change in MELD-Na scores by 12 months
Measured: 12 months
Side effects in both groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start5 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199843
- Sponsor's protocol ID
- ILBS-SBP-03
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial): a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06199843
- Acronym / sponsor ID
- ILBS-SBP-03
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 5 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
SBP is a common complication of cirrhotics with associated increased mortality. After first episode of SBP there is increased risk of again developing SBP, with increased chance of developing resistant organism. So after the first episode of SBP, prophylaxis for prevention of second episode onwards is mandatory and therefore Rifaximin or Norfloxacin is considered. It has been seen that apart from preventing SBP they have other benefits with negligible side effects and therefore it is to be seen what other benefits including mortality benefits these drugs can confer.
Detailed description
Hypothesis:-Rifaximin will be more effective in decreasing the incidence of SBP in patients with cirrhosis and prior episode of SBP
AIM:-.To study the efficacy and safety of Rifaximin vs Norfloxacin in preventing incident SBP, preventing non-SBP infections, and improving transplant free survival in patients with cirrhosis and previous episode of SBP
Methodology Single centered Open labeled Randomized Controlled Trial
Randomization will be done by block randomization method taking block size as 10. Data will be entered in Microsoft Excel and will be analysed by SPSS Version 28.Categorical Data will be represented as frequency (%) and will be analysed using Chi square or Fisher Exact Test as appropriate.Continuous Data will be represented as Mean +/- SD and compared using Student T test or Mann Whitney as per normality conditions are met or not.Beside this an appropriate analysis like survival analysis will be carried out at the time of Data Analysis.P value <0.05 will be considered as significant.
Rescue therapy: To be given to patients who develop SBP while on secondary prophylaxis, these patients will initially be treated by iv medication in hospital settings followed by change in therapy.
- Patients in Rifaximin limb developing SBP will switch to Norfloxacin
- Patients in Norfloxacin limb developing SBP will switch to Rifaximin
Treatment Failure: Defined as development of SBP at end of 6 months or 1 year of treatment.
Study population: age >18 years with prior incident SBP
Study design: Randomised case controlled trial
Study period: 1year after ethical clearance
Sample size: 280 (140 in each arm)
Intervention: This RCT will be conducted at ILBS New Delhi Monitoring and assessment: Monitoring will be done forall the parameters of the objective. Documentation will be done for any adverse effects which will happen.
STATISTICAL ANALYSIS: Assuming incidence of SBP over 6 months is 4% in Rifaximin \& 15% in Norfloxacin Alpha 5% and power 80%. Enrollment of 260 cases (130 in each arm). Assuming dropout rate 10%.Total study cases calculated as 280 (140 in each arm). Random allocation in each arm by block method taking 10 as block size
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: RifaximinRifaximin 550 mg BD |
| Norfloxacin | Active comparator | Drug: NorfloxacinNorfloxacin 400 mg OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18 years
- Cirrhosis (of any etiology) with ascites
- Prior incident SBP
Key exclusion criteria (11 listed)
- Allergy to norfloxacin or rifaximin
- Recent history of upper gastrointestinal bleed (UGIB) within 2 weeks
- Patients with a history of multiple episodes of SBP
- Patients with inoperable or not treatable HCC or other non-hepatic malignancy
- Patients on immunosuppression
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 550 mg BD | Drug | Rifaximin |
| NorfloxacinNorfloxacin 400 mg OD | Drug | Norfloxacin |
Primary outcome
Incidence of recurrence of SBP within 6 months
Time frame: 6 months
15 secondary outcomes
Incidence of recurrence of SBP within12 months
Time frame: 12 months
Incidence of other site infections within 6 months
Time frame: 6 months
Incidence of other site infections within 12 months
Time frame: 12 months
to look for resistance pattern of infection in both norfloxacin and rifampicin group, type of resistant bacteria (MDR/XDR), and response of both groups to rifampicin and norfloxacin in secondary prophylaxis of SBP
Time frame: 12 months
Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 6 months
Time frame: 6 months
Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 12 months)
Time frame: 12 months
Transplant free survival by 6 months
Time frame: 6 months
Transplant free survival by 12 months
Time frame: 12 months
Change in Child-Turcotte-Pugh (CTP) by 6 months
Time frame: 6 months
Change in Model for End-Stage Liver Disease (MELD) scores by 6 months
Time frame: 6 months
Change in Model for End-Stage Liver Disease Sodium (MELD Na) scores by 6 months
Time frame: 6 months
Change in Child-Turcotte-Pugh (CTP) scores by 12 months
Time frame: 12 months
Change in Model for End-Stage Liver Disease (MELD) scores by 12 months
Time frame: 12 months
Change in MELD-Na scores by 12 months
Time frame: 12 months
Side effects in both groups
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 11 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 10 Jan 2024. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Jayashree Biswas, MD (01146300000, jayashreeb790@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recurrence of SBP within 6 months (time frame: 6 months). 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 10 Jan 2024.