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Chagas Disease Diagnostic - Inconclusive Serology

This study has been completed.
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00511589
First received: August 3, 2007
Last updated: March 23, 2011
Last verified: August 2007
History of Changes
  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: Open Label
Official Title: PCR in Blood Cultures of Individuals With Positive and Inconclusive Serology for Chagas' Disease

Resource links provided by NLM:

MedlinePlus related topics: Chagas Disease
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 21, 2013