Chagas Disease Diagnostic - Inconclusive Serology
Sponsor
UPECLIN HC FM Botucatu Unesp (Other)
Overall Status
Completed
CT.gov ID
NCT00511589
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
- 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
PCR in Blood Cultures of Individuals With Positive and Inconclusive Serology for Chagas' Disease
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- individuals with positive or inconclusive results in conventional serological tests: ELISA, HAI and IFI for Chagas disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Univerdidade Estadual Paulista | Botucatu | São Paulo | Brazil | 18600-000 |
Sponsors and Collaborators
- UPECLIN HC FM Botucatu Unesp
Investigators
- Principal Investigator: Mariele Cristina M Picka, MSc, UPECLIN HC FM Botucatu Unesp
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00511589
Other Study ID Numbers:
- upeclin/HC/FMB-Unesp-pre01
First Posted:
Aug 6, 2007
Last Update Posted:
Mar 24, 2011
Last Verified:
Aug 1, 2007