Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Cirrhosis Clinical Trial

Official title:

Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00760032
• Other study ID #: GAS-149-07-09-1
• Secondary ID: REF. 1612
• Status: Withdrawn
• Phase: Phase 4
• First received: September 24, 2008
• Last updated: December 4, 2012

Study information

• Verified date: December 2012
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ascites
• Cirrhosis
• Infections

Intervention

Drug:
• Ciprofloxacin
Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
• Placebo
Placebo capsules, one capsule per day during four weeks.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico	D.f.

Sponsors (2)

Lead Sponsor	Collaborator
Florencia Vargas-Vorackova	Laboratorios Senosiain, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipopolysaccharide binding protein plasma levels		24 weeks	No
Secondary	Severe infection		24 weeks	No
Secondary	Pro- and anti-inflammatory cytokine secretion by PBMN cells		24 weeks	No

External Links

•   Sponsor's Web site