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CTRI Number  CTRI/2021/09/036321 [Registered on: 07/09/2021] Trial Registered Prospectively
Last Modified On: 21/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare effects of Tablet Rifaximin alone and in combination with Tablet Norfloxacin for prevention of re-occuring bacterial infection of abdominal fluid and brain function abnormality due to liver disease.  
Scientific Title of Study   Comparative study of Rifaximin alone versus combination therapy with Norfloxacin for secondary prophylaxis of spontaneous bacterial peritonitis with hepatic encephalopathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tarana Gupta 
Designation  Senior Professor 
Affiliation  Pt BD Sharma Post Graduate Institute of Medical Sciences 
Address  Ward 3, Department of Medicine
PGIMS Rohtak
Rohtak
HARYANA
124001
India 
Phone  9914048899  
Fax    
Email  taranagupta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tarana Gupta 
Designation  Senior Professor 
Affiliation  Pt BD Sharma Post Graduate Institute of Medical Sciences 
Address  Ward 3, Department of Medicine
PGIMS Rohtak

HARYANA
124001
India 
Phone  9914048899  
Fax    
Email  taranagupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaibhav  
Designation  Junior Resident 
Affiliation  Pt BD Sharma Post Graduate Institute of Medical Sciences 
Address  Ward 3, Department of Medicine
PGIMS Rohtak
Rohtak
HARYANA
1240011
India 
Phone  8607799777  
Fax    
Email  gaurvaibhav30@gmail.com  
 
Source of Monetary or Material Support  
Pt.B.D.Sharma PGIMS ROHTAK 
 
Primary Sponsor  
Name  Pt BD Sharma PGIMS Rohtak 
Address  PGIMS Rohtak 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrVaibhav  Pt.B.D.Sharma ,PGIMS , ROHTAK  Ward 3 , Deptt. Of Medicine , PGIMS , ROHTAK
Rohtak
HARYANA 		 8607799777

gaurvaibhav30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination therapy of Tablet Norfloxacin and Tablet Rifaximin  Combination therapy of Tablet Norfloxacin 400 mg once daily + Tablet Rifaximin 550 mg twice daily 
Comparator Agent  Tablet Rifaximin   Tablet Rifaximin 550 mg twice daily for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients with cirrhosis and ascites with hepatic encephalopathy with either gastrointestinal bleed, shock (systolic blood pressure <90 mmHg), fever or other signs of systemic inflammation like pain abdomen, diarrhea as well as in patients with worsening liver or renal function and hepatic encephalopathy shall be screened for spontaneous bacterial peritonitis by diagnostic paracentesis 
 
ExclusionCriteria 
Details  1. Age <18 years or > 70 years
2. Pregnant females
3. Patients with chronic respiratory or kidney disease
4. Patients with diabetes mellitus or hypertension
5. Patients with hepatocellular carcinoma
6. Patients with abnormal ECG or chest radiograph 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Recurrent episodes of spontaneous bacterial peritonitis and/or hepatic encephalopathy till next 3 months
28 day and 90 day mortality 		 Recurrent episodes of spontaneous bacterial peritonitis and/or hepatic encephalopathy till next 3 months
28 day and 90 day mortality 
 
Secondary Outcome  
Outcome  TimePoints 
Number of hospitalisation over next 3 months
Episodes of upper GI bleed, acute kidney injury over next 3 months
Change in model for end stage liver disease and Child Turcotte Pugh score over next 3 months 		 Number of hospitalisation over next 3 months
Episodes of upper GI bleed, acute kidney injury over next 3 months
Change in model for end stage liver disease and Child Turcotte Pugh score over next 3 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2021 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gaurvaibhav30@gmail.com].

  6. For how long will this data be available start date provided 30-08-2022 and end date provided 30-08-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - gaurvaibhav30@gmail.com
Brief Summary  

 The advancement of cirrhosis leads to many complications affecting multiple organ system and includes ascites, hepatic encephalopathy, variceal bleeding etc. It is also associated with development of Spontaneous Bacterial Peritonitis which is a serious complication leading to rapid onset of renal failure and metabolic disorders. These patients are at higher risk of developing acute-on-chronic liver failure which is associated with high morbidity and mortality. (1) Frequent hospitalization with requirement of intensive care in these patients puts a significant burden on the healthcare system and resources. (2)Additionally development of hepatic encephalopathy confers poor prognosis. The 1 year mortality approaches to approximately 64% following development of hepatic encephalopathy in cirrhotic patients in comparison to 17% following a diagnosis of cirrhosis in the absence of any evidence of decompensation. (3)Thus initiation of timely and adequate management of Spontaneous Bacterial Peritonitis in these patients is required to decrease morbidity, mortality and burden on the healthcare resources.

The management of spontaneous bacterial peritonitis is primarily based on three aspects. Firstly, a rapid diagnosis is crucial to start empiric antibiotic treatment taking into account the local bacteriology. Secondly, stratification of patients to identify candidates to receive intravenous albumin to reduce the risk of acute kidney injury and death. Thirdly, mandatory lifelong prophylaxis after resolution of the infection. Spontaneous Bacterial Peritonitis prophylaxis is indicated particularly in three high-risk subgroups of patients: Subjects with acute gastrointestinal bleeding, patients with low total protein content in ascitic fluid and advanced liver cirrhosis, and those with a previous history of SBP (secondary prophylaxis). 

 Although various studies have been conducted recently to evaluate efficacy of Rifaximin and Norfloxacin for secondary prophylaxis of Spontaneous Bacterial Peritonitis which have shown their comparable efficacy but there is paucity of literature regarding the efficacy of combination therapy in the secondary prophylaxis of Spontaneous Bacterial Peritonitis.

The present study was conducted to compare the efficacy of Rifaximin alone with its combination therapy with Norfloxacin for secondary prophylaxis of Spontaneous Bacterial Peritonitis in patients with cirrhosis with hepatic encephalopathy

 

 


 
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