Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

NCT ID: NCT00760032

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis Ascites Infections

Keywords

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Cirrhosis Ascites Lipopolysaccharide binding protein Infections Cytokines Ciprofloxacin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Active

Ciprofloxacin

Group Type EXPERIMENTAL

Ciprofloxacin

Intervention Type DRUG

Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules, one capsule per day during four weeks.

Interventions

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Ciprofloxacin

Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.

Intervention Type DRUG

Placebo

Placebo capsules, one capsule per day during four weeks.

Intervention Type DRUG

Other Intervention Names

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Ciproflox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role collaborator

Florencia Vargas-Vorackova

OTHER

Sponsor Role lead

Responsible Party

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Florencia Vargas-Vorackova

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, D.f., Mexico

Site Status

Countries

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Mexico

Related Links

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http://www.innsz.mx

Sponsor's Web site

Other Identifiers

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REF. 1612

Identifier Type: -

Identifier Source: secondary_id

GAS-149-07-09-1

Identifier Type: -

Identifier Source: org_study_id