NCT00511589

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
Last Updated

March 24, 2011

Status Verified

August 1, 2007

First QC Date

August 3, 2007

Last Update Submit

March 23, 2011

Conditions

ParasitemiaProtozoan Infections

Interventions

chagas disease diagnosticOTHER

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerdidade Estadual Paulista

Botucatu, São Paulo, 18600-000, Brazil

Location

MeSH Terms

Conditions

ParasitemiaProtozoan Infections

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mariele Cristina M Picka, MSc

    UPECLIN HC FM Botucatu Unesp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 6, 2007

Last Updated

March 24, 2011

Record last verified: 2007-08

Locations

BR(1)