Chagas Disease Diagnostic - Inconclusive Serology

NCT ID: NCT00511589

Last Updated: 2011-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Parasitemia; Protozoan Infections

Study Design

• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

chagas disease diagnostic

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role: lead

Principal Investigators

Mariele Cristina M Picka, MSc

Role: PRINCIPAL_INVESTIGATOR

UPECLIN HC FM Botucatu Unesp

Locations

Univerdidade Estadual Paulista

Botucatu, São Paulo, Brazil

Countries

Brazil

Other Identifiers

upeclin/HC/FMB-Unesp-pre01

Identifier Type: -

Identifier Source: org_study_id