Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Florencia Vargas-Vorackova

Status and phase: Withdrawn; Phase 4

Conditions: Cirrhosis; Infections; Ascites

Treatments: Drug: Ciprofloxacin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00760032

REF. 1612

GAS-149-07-09-1

Details and patient eligibility

About

The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cirrhosis
• Ascites
• No history of spontaneous bacterial peritonitis and/or < 1 g of protein in ascites
• No antibiotic use in previous 6 weeks
• Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
• Absence of GI bleeding or encephalopathy
• Signature of informed consent

Exclusion criteria

• Ciprofloxacin contraindication
• Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
• > 13 Child-Pugh points
• Inability to attend to regular visits
• Current alcohol intake
• Terminal disease with < 24 week expected survival

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Ciprofloxacin

Treatment:

Drug: Ciprofloxacin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo