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Chagas Disease Diagnostic - Inconclusive Serology

This study has been completed.
Information provided by:
UPECLIN HC FM Botucatu Unesp Identifier:
First received: August 3, 2007
Last updated: March 23, 2011
Last verified: August 2007
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.

Condition Intervention
Parasitemia Protozoan Infections Other: chagas disease diagnostic

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: PCR in Blood Cultures of Individuals With Positive and Inconclusive Serology for Chagas' Disease

Resource links provided by NLM:

Further study details as provided by UPECLIN HC FM Botucatu Unesp:


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • individuals with positive or inconclusive results in conventional serological tests: ELISA, HAI and IFI for Chagas disease
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Please refer to this study by its identifier: NCT00511589

Univerdidade Estadual Paulista
Botucatu, São Paulo, Brazil, 18600-000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Principal Investigator: Mariele Cristina M Picka, MSc UPECLIN HC FM Botucatu Unesp
  More Information Identifier: NCT00511589     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-pre01
Study First Received: August 3, 2007
Last Updated: March 23, 2011

Additional relevant MeSH terms:
Chagas Disease
Protozoan Infections
Euglenozoa Infections
Parasitic Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on September 20, 2017