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Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

This study has been withdrawn prior to enrollment.
(was not possible to measure LBP levels because we cannot found the kit)
Sponsor:
Collaborator:
Laboratorios Senosiain, S.A. de C.V.
Information provided by (Responsible Party):
Florencia Vargas-Vorackova, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT00760032
First received: September 24, 2008
Last updated: December 4, 2012
Last verified: December 2012

September 24, 2008
December 4, 2012
Not Provided
Not Provided
Lipopolysaccharide binding protein plasma levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00760032 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
  • Cirrhosis
  • Ascites
  • Infections
  • Drug: Ciprofloxacin
    Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
    Other Name: Ciproflox
  • Drug: Placebo
    Placebo capsules, one capsule per day during four weeks.
  • Experimental: Active
    Ciprofloxacin
    Intervention: Drug: Ciprofloxacin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00760032
GAS-149-07-09-1, REF. 1612
Yes
Florencia Vargas-Vorackova, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Florencia Vargas-Vorackova
Laboratorios Senosiain, S.A. de C.V.
Principal Investigator: Florencia Vargas-Vorackova, M.D., Ph.D. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP