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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:

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

Exclusion Criteria:

  1. Clinically suspected piogenous liver abscess
  2. Positive hemoculture
  3. Negative ELISA for amoebic antigens
  4. Immunosupresion (HIV)
  5. Abdominal or biliary surgery antecedents
  6. 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
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 October 17, 2008




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