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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.

Comparative study of Rifaximin alone versus combination therapy with Norfloxacin for secondary prophylaxis of spontaneous bacterial peritonitis with hepatic encephalopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036321
Enrollment
80
Registered
2021-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Combination therapy of Tablet Norfloxacin and Tablet Rifaximin: Combination therapy of Tablet Norfloxacin 400 mg once daily + Tablet Rifaximin 550 mg twice daily Control Intervention1:

Sponsors

Pt BD Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Age 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

Design outcomes

Primary

MeasureTime frame
Recurrent episodes of spontaneous bacterial peritonitis and/or hepatic encephalopathy till next 3 months 28 day and 90 day mortalityTimepoint: Recurrent episodes of spontaneous bacterial peritonitis and/or hepatic encephalopathy till next 3 months 28 day and 90 day mortality

Secondary

MeasureTime frame
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 monthsTimepoint: 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

Countries

India

Contacts

Public ContactDr Vaibhav

Pt BD Sharma Post Graduate Institute of Medical Sciences

taranagupta@gmail.com9914048899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026