- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787968
Congenital Transmission of Lineages I and II of Trypanosoma Cruzi
November 15, 2016 updated by: Dr. Pierre Buekens, Tulane University School of Public Health and Tropical Medicine
T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII, including all non-TcI).
TcI is predominant in Mexico and Central America, while TcII (non-TcI) is predominant in most of South America, including Argentina.
In recent studies from Argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent.
By contrast, we know very little about the congenital transmission of TcI.
It has been suggested that congenital transmission of T. cruzi is strain related, and there is an urgent need to know if TcI transmits differently than TcII (non-TcI).
Our primary hypothesis is that congenital transmission rates are different for TcI versus TcII.
Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where TcI is predominant versus regions where TcII (non-TcI) is predominant.
To test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina.
We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months.
We will also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings.
We will estimate the exposure to vectors in the household.
In addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings.
The specific aims of this study are: 1) To determine the rate of congenital transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to TcI and TcII seropositive women.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
28348
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
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Buenos Aires, Argentina
- Institute for Clinical Effectiveness and Health Policy
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Brussels, Belgium
- Laboratory of Parasitology, Universite Libre de Bruxelles
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Tegucigalpa, Honduras
- Inst. de Enfermedades Infecciosas y Parasitol Antonio Vidal
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Merida, Mexico
- Lab. de Parasitologia, Universidad Autonoma de Yucatan
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane School of Public Health and Tropical Medicine
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women delivering in participating hospitals.
Description
Inclusion Criteria:
- Women 18 years old or more, informed consent, live birth.
Exclusion Criteria:
- Women residing outside of the follow-up area.
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
Cohorts and Interventions
Group / Cohort |
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TcI, TcII
TcI: T. cruzi seropositive mothers from countries where TcI predominates, or/and with TcI genotyping TcII: T. cruzi seropositive mothers from countries where TcII (non-TcI) predominates, or/and with TcII (non-TcI) genotyping
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Congenital transmission of Trypanosoma cruzi
Time Frame: Two years
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We will identify infants who are congenitally infected by performing parasitological examinations on cord blood, on venous blood at 4-8 weeks, and serological follow-up at 10 months.
Standard PCR, quantitative real-time PCR (qPCR), and T. cruzi genotyping will be performed on maternal blood and cord blood.
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Two years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Birth outcomes
Time Frame: Two years
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Perinatal outcomes (premature rupture of the membranes, birthweight, gestational age, IUGR, and neonatal complications) will be measured among infected and uninfected infants with seropositive mothers, and birthweight will be measured among infected and uninfected siblings.
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Two years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Pierre Buekens, MD, PhD, Tulane SPHTM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 7, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (Estimate)
February 11, 2013
Study Record Updates
Last Update Posted (Estimate)
November 16, 2016
Last Update Submitted That Met QC Criteria
November 15, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AI083563 (U.S. NIH Grant/Contract)
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.
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