Chagas Disease Diagnostic - Inconclusive Serology

Not Applicable

Completed

• Conditions: Parasitemia; Protozoan Infections

• Registration Number: NCT00511589
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study First Submitted: 2007-08-03
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-06
• Last Update Submitted: 2011-03-23
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Univerdidade Estadual Paulista; 🇧🇷 Botucatu, São Paulo, Brazil