Skip to content

Chagas Disease Diagnostic - Inconclusive Serology

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00511589
Enrollment
Unknown
Registered
2007-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2011-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parasitemia, Protozoan Infections

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.

Interventions

OTHERchagas disease diagnostic

Sponsors

UPECLIN HC FM Botucatu Unesp
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026