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A clinical trial to compare two drugs, norfloxacin versus rifaximin in patients with fluid collection in the stomach

A randomised controlled trial to compare the efficacy of norfloxacin with rifaximin in the prophylaxis of spontaneous bacterial peritonitis - NRSBP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030863
Enrollment
68
Registered
2021-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K652- Spontaneous bacterial peritonitis

Interventions

Intervention1: Rifaximin: Per oral 800 mg in two divided doses after meals for 3 months Control Intervention1: Norfloxacin: Per oral 400 mg daily for 3 months

Sponsors

Dr Sanbanki Pala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Ascitic fluid total protein 2) Child Pugh score > 9 3) Serum bilirubin > 3 mg/dL 4) Serum creatinine > 1.2 mg/dL 5) BUN > 25 mg/dL 6) serum sodium < 130 mEq/L

Exclusion criteria

Exclusion criteria: 1) Patients allergic to quinolones 2) Patients diagnosed with hepatocellular carcinoma 3) Infections other than SBP 4) Pregnant women

Design outcomes

Primary

MeasureTime frame
1) Efficacy in prophylaxis of SBP in patients with Child Pugh Score C liver cirrhosisTimepoint: 3 months—

Secondary

MeasureTime frame
1) Prevention of hepatic encephalopathyTimepoint: 3 months;2) Prevention of recurrence of SBPTimepoint: 3 months—

Countries

India

Contacts

Public ContactDr Purwa Doke

Bharati Vidyapeeth (Deemed To Be) University Medical College

dadasahebmaindad@yahoo.com9552993311

Outcome results

None listed

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