Prognosis of Failure Treatment of Amebic Liver Abscess | NCT00641992

Studies
Prognosis of Failure Treatment of Amebic Liver Abscess

NCT00641992

Sponsor

Universidad Autonoma de San Luis Potosí

Status

Completed

Last Update Posted

Mar 24, 2008Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Amebic Liver Abscess

Interventions

Not provided

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

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1999

Primary Completion Date

Apr 2000Actual

Completion Date

Apr 2000Actual

First Submitted Date

Mar 12, 2008

First Submission Date that Met QC Criteria

Mar 17, 2008

First Posted Date

Mar 24, 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

Mar 17, 2008

Last Update Posted Date

Mar 24, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Universidad Autonoma de San Luis PotosíOTHER

Collaborators

Name	Class
Universidad Nacional Autonoma de Mexico	OTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	OTHER
Hospital Central "Dr. Ignacio Morones Prieto"	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Response to medical treatment
2		Failure to medical treatment (surgery or percutaneous resolution)

Interventions

Not provided

Measure	Description	Time Frame
Failure of medical treatment		Day 4

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess.
Both genders
Older 15 years

Exclusion Criteria:

Clinically suspected piogenous liver abscess
Positive hemoculture
Negative ELISA for amoebic antigens
Immunosupresion (HIV)
Abdominal or biliary surgery antecedents
Abdominal neoplasia antecedents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

sequential patients with clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martín Sánchez-Aguilar 1, MSc	1. Department of Experimental Surgery, Faculty of Medicine, Universidad Autónoma de San Luis Potosí	Principal Investigator
Onofre Morán-Mendoza, PhD	Department of Clinical Epidemiology, Faculty of Medicine, Universidad Autónoma de San Luis Potosí	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán".		Mexico City	Mexico DF		Mexico

Condition Browse Module

MeSH Terms

ID	Term
D008101	Liver Abscess, Amebic

Ancestor Terms

ID	Term
D008109	Liver Diseases, Parasitic
D010272	Parasitic Diseases
D007239	Infections
D000562	Amebiasis

Browse Leaves

Not provided

Browse Branches

Not provided