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Prevention of infection in Liver Failure Patients.

Norfloxacin Prophylaxis for prevention of bacterial infections in Acute On Chronic Liver Failure Patients- A Placebo-Controlled Randomized Trial. - NPPSA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021548
Enrollment
140
Registered
2019-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: K729- Hepatic failure, unspecified

Interventions

Intervention1: Norfloxacin: Norfloxacin 400mg once daily for 30 days + SMT (Standard medical therapy). Control Intervention1: Placebo: Matched Placebo once daily for 30 days + SMT(Standard medical the

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: ACLF patients aged between 18-75 years, either admitted or attending the out-patient department will be recruited for the study.

Exclusion criteria

Exclusion criteria: 1. Patients with sepsis â?? fever, positive blood, and urine cultures, procalcitonin >2, Allergy to fluoroquinolones. 2.Patients in the intensive care unit 3.Renal failure (S. Creatinine >2.5mg%) 4.Pregnancy 5.Patients with a history of Spontaneous bacterial peritonitis 6.Patients with shock requiring vasopressor support 7.Patients with malignancy 8.Recent Gastrointestinal bleeding ( 9.Patients with a history of Hepatic encephalopathy and /or on Rifaximin therapy 10.Patients who received fluoroquinolones in last one month 11.Patients on intravenous antibiotics 12.Refusal to participate

Design outcomes

Primary

MeasureTime frame
Incidence of sepsisTimepoint: at day 30

Secondary

MeasureTime frame
Effect of norfloxacin on Endotoxin levelsTimepoint: on day 7, 30;To study the safety and tolerability of the Norfloxacin.Timepoint: at day 30;Transplant-free survivalTimepoint: at day 30, 90.

Countries

India

Contacts

Public ContactAnand V Kulkarni

AIG Hospital

anandvk90@gmail.com8553322434

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026