Chagas Disease Diagnostic - Inconclusive Serology

March 23, 2011 updated by: UPECLIN HC FM Botucatu Unesp

PCR in Blood Cultures of Individuals With Positive and Inconclusive Serology for Chagas' Disease

T. cruzi infection affects approximately five million people in Brazil. The diagnosis of the chronic phase of infection is performed by indirect serological methods which, nevertheless, leave inconclusive results. One of the direct methods used for T. cruzi identification, blood culture in LIT (liver infusion tryptose) medium, presents low sensitivity in that phase of the disease. A negative result does not eliminate the possibility of infection, but a positive test has high absolute diagnostic value, which enables the indication of antiparasitic treatment. Molecular diagnosis (PCR) in this phase is promising and can be used as a confirmatory test, particularly when individuals present inconclusive results in conventional serological tests, such as ELISA, HAI and IFI. This study aimed at improving blood culture sensitivity in LIT medium by performing PCR in individuals with positive and inconclusive serology for chagasic infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18600-000
        • Univerdidade Estadual Paulista

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • individuals with positive or inconclusive results in conventional serological tests: ELISA, HAI and IFI for Chagas disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Investigators

  • Principal Investigator: Mariele Cristina M Picka, MSc, UPECLIN HC FM Botucatu Unesp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 6, 2007

Study Record Updates

Last Update Posted (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/HC/FMB-Unesp-pre01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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