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Clinical Trials/NCT00511589
NCT00511589CompletedNot Applicable

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

UPECLIN HC FM Botucatu Unesp2 sites in 1 countryStarted: August 6, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Locations
2

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Investigators

Sponsor
UPECLIN HC FM Botucatu Unesp
Sponsor Class
Other

Study Sites (2)

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