Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2008 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Recruitment status was Recruiting

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

Genetics Home Reference related topics: North American Indian childhood cirrhosis

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
Experimental: Active Ciprofloxacin	Drug: Ciprofloxacin Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks. Other Name: Ciproflox
Placebo Comparator: Placebo 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
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:	Florencia Vargas-Vorackova, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:	NCT00760032 History of Changes
Other Study ID Numbers:	GAS-149-07-09-1, REF. 1612
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
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:

Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Ciprofloxacin

Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012