Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511589
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2007-08-03
Brief Title:
Chagas Disease Diagnostic - Inconclusive Serology
Sponsor:
UPECLIN HC FM Botucatu Unesp
Organization:
UPECLIN HC FM Botucatu Unesp
Study Overview
Official Title:
PCR in Blood Cultures of Individuals With Positive and Inconclusive Serology for Chagas Disease
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None