| CTRI Number |
CTRI/2025/06/089677 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Double Blind Placebo Controlled Trial Assessing Rifaximins Effect on Infected Pancreatic Necrosis in Patients with Acute Necrotizing Pancreatitis. |
|
Scientific Title of Study
|
A randomized double-blind placebo-controlled trial to evaluate the effect of Rifaximin to reduce the incidence of infected pancreatic Necrosis in patients with Acute necrotizing pancreatitis without persistent organ failure. |
| Trial Acronym |
PAN-RIX |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Garg |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology
New Delhi
DELHI
110029
India |
| Phone |
9810038116 |
| Fax |
|
| Email |
pgarg10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya J Mahapatra |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology
New Delhi
DELHI
110029
India |
| Phone |
9990420767 |
| Fax |
|
| Email |
soumyajagannath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Tabish |
| Designation |
Pancreatology Fellow |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology
New Delhi
DELHI
110029
India |
| Phone |
7289976940 |
| Fax |
|
| Email |
mdtabish008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Garg |
All India Institute of Medical Sciences |
Department of Gastroenterology, Ansari Nagar, New Delhi
New Delhi
DELHI |
9810038116
pgarg10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K858||Other acute pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Rifaximin Group |
Patients will receive oral rifaximin at a dose of 550 mg 2 times daily for 6 weeks. |
| Comparator Agent |
Placebo Group |
Patients will receive a matching placebo tablet with an identical appearance to rifaximin, following the same dosing regimen as the rifaximin group. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults (age 12-75 years) diagnosed with acute necrotizing pancreatitis without any persistent organ failure presenting beyond first week till 6 week of onset of illness. |
|
| ExclusionCriteria |
| Details |
1. Persistent organ failure
2. evidence of infected pancreatic necrosis at time of screening
3. prior drainage and/or necrosectomy
4. contraindication to enteral feeding or not tolerating enteral feed
5. Major comorbidity such as decompensated cirrhosis, heart failure, significant lung parenchymal or airway disease, advanced chronic kidney disease
6. pregnancy
7. patients with chronic pancreatitis
8. refusal to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Infected (peri) pancreatic fluid collections. |
From randomization to 90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for drainage of collection (endoscopic, percutaneous or surgical)
Need for necrosectomy
Hospital readmission rate within 42 days of discharge
Mortality rate at 90 days
Length of hospital stay (days)
Need for antibiotics for suspected infected pancreatic fluid collections
Duration of antibiotic use
Incidence of new-onset organ failure
Duration of Organ failure
Time to readmission after discharge
adverse events associated with rifaximin administration
Duration of ICU stay
60 days alive and out of hospital (DAOH60) post discharge
Change in gut microbiome at baseline and at day 42
Improvement in BMI, Albumin, CRP, Faecal elastase |
From randomization to 42 days, 60 days, and 90 days. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute pancreatitis is a common inflammatory disease
of the pancreas with a significant healthcare burden. While most cases are mild
and self-limiting, approximately 10-20% of patients progress to moderately
severe or severe AP, which carries a high risk of complications. Overall
mortality of AP patients is approximately 5% and can reach up to 20-30% in
patients with severe acute pancreatitis and infected necrosis. One of the most
concerning complications is infectious complications, occurring in up to 40-70%
of patients with acute necrotizing pancreatitis. Rifaximin offers a targeted approach
with a favourable safety profile. Rifaximin has emerged as a potential
therapeutic option for gut decontamination in various GI disorders. Previous
research on rifaximin in acute pancreatitis has been limited. Administration of
rifaximin reduces infectious complications and hospital readmission rates in
patients with moderately severe and severe acute pancreatitis with
peripancreatic collections compared to placebo. This randomized
controlled trial is needed to definitively assess efficacy and safety. |