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NCT00511589 Clinical Trial

Chagas Disease Diagnostic - Inconclusive Serology

Protozoan Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00511589
Other study ID # upeclin/HC/FMB-Unesp-pre01
Secondary ID
Status Completed
Phase N/A
First received August 3, 2007
Last updated March 23, 2011

Study information
Verified date August 2007
Source UPECLIN HC FM Botucatu Unesp
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• chagas disease diagnostic

Locations
Country Name City State
Brazil Univerdidade Estadual Paulista Botucatu São Paulo

Sponsors (1)
Lead Sponsor Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

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