Lipopolysaccharide Binding Protein and Development of Inf... | NCT00760032

Studies
Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

NCT00760032

Sponsor

Florencia Vargas-Vorackova

Status

Withdrawn

Last Update Posted

Dec 5, 2012Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Cirrhosis
Ascites
Infections

Interventions

Ciprofloxacin
Placebo

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
REF. 1612

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

was not possible to measure LBP levels because we cannot found the kit

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2012

Last Update Posted Date

Dec 5, 2012Estimated

Name	Class
Laboratorios Senosiain, S.A. de C.V.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Ciprofloxacin	Drug: Ciprofloxacin
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin	Drug	Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lipopolysaccharide binding protein plasma levels		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Severe infection		24 weeks
Pro- and anti-inflammatory cytokine secretion by PBMN cells		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florencia Vargas-Vorackova, M.D., Ph.D.	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran		México	D.f.	14000	Mexico

Label	URL
Sponsor's Web site	View source

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D001201	Ascites
D007239	Infections

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002939	Ciprofloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided