Can survival of patients with ascites an liver cirrhosis, who never had a peritonitis before, be improved by an antibiotic prophylaxis, if the patients carry a special genetic risk factor (NOD2)?

Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver cirrhosis and ascites (INCA trial) - INCA-Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001626-26-DE

Enrollment

186

Registered

2013-09-30

Start date

2015-01-26

Completion date

Unknown

Last updated

2021-10-18

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

Conditions

Liver cirrhosis and ascites MedDRA version: 20.0 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 100000004871 MedDRA version: 20.0 Level: PT Classification code 10003445 Term: Ascites System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Norfloxacina ABC 400 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: norfloxacin Other descriptive name: NORFLOXACIN Concentration unit: mg milligram(s) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 186 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 186

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: Does antibiotic duration prophylaxis with Norfloxacin lead to enhanced survival after 12 months.;Secondary Objective: Does antibiotic duration prophylaxis have an Impact on the risk for spontaneous bacterial peritonitis.;Primary end point(s):	—

Countries

Germany

Contacts

Public ContactDr. Christoph Coch

Studienzentrale des Studienzentrum Bonn (SZB)

ccoch@uni-bonn.de0049228287-16040

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 18, 2026