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Chagas Disease Diagnostic - Inconclusive Serology

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511589
First Posted: August 6, 2007
Last Update Posted: March 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UPECLIN HC FM Botucatu Unesp
  Purpose
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:

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • individuals with positive or inconclusive results in conventional serological tests: ELISA, HAI and IFI for Chagas disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511589


Locations
Brazil
Univerdidade Estadual Paulista
Botucatu, São Paulo, Brazil, 18600-000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Mariele Cristina M Picka, MSc UPECLIN HC FM Botucatu Unesp
  More Information

ClinicalTrials.gov Identifier: NCT00511589     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-pre01
First Submitted: August 3, 2007
First Posted: August 6, 2007
Last Update Posted: March 24, 2011
Last Verified: August 2007

Additional relevant MeSH terms:
Chagas Disease
Parasitemia
Protozoan Infections
Trypanosomiasis
Euglenozoa Infections
Parasitic Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes