Antibiotic therapy in severe alcoholic hepatitis

Randomised open-labelmulticenter study evaluating ciprofloxacin in severe alcoholic hepatitis in addition to prednisolon therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003727-11-FI

Enrollment

150

Registered

2013-09-24

Start date

2014-02-26

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Alcoholic hepatitis

Interventions

Trade Name: Ciprofloxacin Product Name: Ciprofloxacin Pharmaceutical Form: Tablet Trade Name: Prednisolone Product Name: Prednisolon Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hospitalised patients with evere alcoholic hepatitis defined by modified Maddrey score over 300, patients over 18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - viral hepatitis B or C - significant gastrointestinal bleeding (melaena) in past 4 days - severe untreated bacterial infection - severe renal failure (serum creatinine over 150 umol/l) - patients previously enrolled to this study - any other liver disease significantly affecting the course of alcoholic hepatitis (e.g. autoimmune hepatitis, untreated haemochromatosis) - any malignancy not in remission - patient unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of ciprofloxacin therapy in adittion to prednisolone therapy to mortality in severe alcoholic hepatitis;Secondary Objective: Effects of ciiprofloxacin to prognostic scores in severe alocohlic hepatitis;Primary end point(s): Mortality at day 28, at 3 months, 6 months and 12 months;Timepoint(s) of evaluation of this end point: day 28, 3 months, 6 months	—

Secondary

Measure	Time frame
Secondary end point(s): - Proportion of patients with early change in bilirubin levels (ECBL= S-Bil(Day 0)-S-Bil(Day7 )>0 - Proportion of patients with Lille Score >0.45 day 7 - Recovery of liver function parameters in 1 and 3 months ;Timepoint(s) of evaluation of this end point: day 7 and 28, 3 months	—

Countries

Finland

Outcome results

None listed

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