An interventional study of Rifaximin and Norfloxacin in Spontaneous Bacterial Peritonitis, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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.
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.
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
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 280 is above the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rifaximin 550 mg BD
Drug: Rifaximin
Norfloxacin 400 mg OD
Drug: Norfloxacin
Rifaximin 550 mg BD
Norfloxacin 400 mg OD
Incidence of recurrence of SBP within 6 months
Time frame: 6 months
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2024; primary completion for Dec 2024, 11 months later.
Of 23 interventional studies with no phase under Peritonitis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 11 months is below that.
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This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifaximin
Institute of Liver and Biliary Sciences, India →