Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

This study is currently recruiting participants.

Verified by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, September 2008

First Received: September 24, 2008 No Changes Posted

Sponsor:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborator:	Laboratorios Senosiain, S.A. de C.V.
Information provided by:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:	NCT00760032

Purpose

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.

Condition	Intervention	Phase
Cirrhosis Ascites Infections	Drug: Ciprofloxacin Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:

Lipopolysaccharide binding protein plasma levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severe infection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Pro- and anti-inflammatory cytokine secretion by PBMN cells [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental Ciprofloxacin	Drug: Ciprofloxacin Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
Placebo: Placebo Comparator Placebo	Drug: Placebo Placebo capsules, one capsule per day during four weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760032

Contacts

Contact: Felix I Tellez-Avila, M.D., M.Sc.

(5255)5573-3418

felixtelleza@gmail.com

Locations

Mexico, D.F.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Recruiting
Mexico, D.F., Mexico, 14000
Contact florvar@quetzal.innsz.mx
Principal Investigator: Florencia Vargas-Vorackova, M.D., Ph.D.
Sub-Investigator: Felix I Tellez-Avila, M.D., M.Sc.
Sub-Investigator: Ada M Franco-Guzman, M.D.
Sub-Investigator: Roberto Ruiz-Cordero, M.D.
Sub-Investigator: Jose Sifuentes-Osornio, M.D.

Sponsors and Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Laboratorios Senosiain, S.A. de C.V.

Investigators

Principal Investigator:

Florencia Vargas-Vorackova, M.D., Ph.D.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

More Information

Additional Information:

Sponsor's Web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Florencia Vargas-Vorackova )
Study ID Numbers:	GAS-149-07-09-1, REF. 1612
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00760032 History of Changes
Health Authority:	Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Cirrhosis
Ascites
Lipopolysaccharide binding protein

Infections
Cytokines
Ciprofloxacin

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Fibrosis
Enzyme Inhibitors
Liver Cirrhosis
Infection

Pharmacologic Actions
Ciprofloxacin
Pathologic Processes
Digestive System Diseases
Ascites
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010