Prognosis of Failure Treatment of Amebic Liver Abscess

This study has been completed.

Sponsors and Collaborators:	Universidad Autonoma de San Luis Potosí Universidad Nacional Autonoma de Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by:	Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:	NCT00641992

Purpose

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.

Condition
Amebic Liver Abscess

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Prognosis Factors of the Response After Medical Treatment of Amebic Liver Abscess

Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:

Failure of medical treatment [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	40
Study Start Date:	May 1999
Study Completion Date:	April 2000
Primary Completion Date:	April 2000 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Response to medical treatment
2 Failure to medical treatment (surgery or percutaneous resolution)

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641992

Locations

Mexico
Department of Surgery, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán".
Mexico DF, Mexico
Faculty of Medicine, Universidad Autónoma de San Luis Potosí
San Luis Potosi, Mexico, 78210

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí

Universidad Nacional Autonoma de Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

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

More Information

Responsible Party:	Epidemiologia Clinica, Universidad Autonoma de San Luis Potosí ( Dr. Martin Sanchez Aguilar )
Study ID Numbers:	PFP-ALA
Study First Received:	March 12, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00641992
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Universidad Autonoma de San Luis Potosí:

amebic liver abscess
failure
prognosis

Study placed in the following topic categories:

Protozoan Infections
Amebiasis
Abdominal Abscess
Liver Abscess, Amebic
Liver Diseases
Digestive System Diseases

Liver Abscess
Abscess
Suppuration
Parasitic Diseases
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Sarcodina Infections
Sarcomastigophora Infections
Infection
Liver Diseases, Parasitic

ClinicalTrials.gov processed this record on January 16, 2009