NCT00760032

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

First QC Date

September 24, 2008

Last Update Submit

December 4, 2012

Conditions

CirrhosisAscitesInfections

Keywords

CirrhosisAscitesLipopolysaccharide binding proteinInfectionsCytokinesCiprofloxacin

Outcome Measures

Primary Outcomes (1)

  • Lipopolysaccharide binding protein plasma levels

    24 weeks

Secondary Outcomes (2)

  • Severe infection

    24 weeks

  • Pro- and anti-inflammatory cytokine secretion by PBMN cells

    24 weeks

Study Arms (2)

Active

EXPERIMENTAL

Ciprofloxacin

Drug: Ciprofloxacin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CiprofloxacinDRUG

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

Also known as: Ciproflox
Active
PlaceboDRUG

Placebo capsules, one capsule per day during four weeks.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, D.f., 14000, Mexico

Location

Related Links

MeSH Terms

Conditions

FibrosisAscitesInfections

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

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

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

ME(1)