- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00511589
Chagas Disease Diagnostic - Inconclusive Serology
March 23, 2011 updated by: UPECLIN HC FM Botucatu Unesp
PCR in Blood Cultures of Individuals With Positive and Inconclusive Serology for Chagas' Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Botucatu, São Paulo, Brazil, 18600-000
- Univerdidade Estadual Paulista
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- individuals with positive or inconclusive results in conventional serological tests: ELISA, HAI and IFI for Chagas disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mariele Cristina M Picka, MSc, UPECLIN HC FM Botucatu Unesp
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 3, 2007
First Submitted That Met QC Criteria
August 3, 2007
First Posted (Estimate)
August 6, 2007
Study Record Updates
Last Update Posted (Estimate)
March 24, 2011
Last Update Submitted That Met QC Criteria
March 23, 2011
Last Verified
August 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- upeclin/HC/FMB-Unesp-pre01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Protozoan Infections
-
60 Degrees Pharmaceuticals LLCNot yet recruiting
-
University Hospital, Strasbourg, FranceRecruitingBabesiosis, HumanFrance
-
ImugenAmerican National Red Cross; Memorial Blood Centers, Minnesota; Rhode Island...Completed
-
University of Mississippi Medical CenterMississippi State Department of HealthCompletedTrichomonas InfectionsUnited States
-
International Centre for Diarrhoeal Disease Research...University of VirginiaCompleted
-
University of VirginiaInternational Centre for Diarrhoeal Disease Research, BangladeshActive, not recruiting
-
University of Alabama at BirminghamNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
Tufts UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
Romark Laboratories L.C.UnknownHIV Infections | CryptosporidiosisUnited States
Clinical Trials on chagas disease diagnostic
-
Abbott Diagnostics DivisionCompleted
-
Abbott Diagnostics DivisionCompleted
-
Sociedad Espanola de Angiologia y Cirugia VascularUnknown
-
Dnipropetrovsk State Medical AcademyUnknownIschemic Heart Disease | Prostate AdenocarcinomaUkraine
-
Institut de Recherche pour le DeveloppementInstituto de Investigación Hospital Universitario La PazCompletedChagas' Disease (Chronic) With Other Organ InvolvementBolivia
-
Erasmus Medical CenterBayer; University Medical Center Groningen; University of Erlangen-Nürnberg; Queen... and other collaboratorsCompletedCoronary Artery DiseaseNetherlands
-
InBios International, Inc.Completed
-
Hospital de Niños R. Gutierrez de Buenos AiresThe Hospital for Sick Children; Thrasher Research Fund; Universidad Nacional... and other collaboratorsCompletedChagas DiseaseArgentina
-
Kakatiya UniversityCompletedComplication | Cardiac Event | Gender DiscriminationIndia
-
MAAB (Shanghai) Medical Device LimitedRD Biomed LtdCompletedGastro-esophageal Reflux DiseaseChina