Trial record 13 of 20 for:    Open Studies | "Chagas Disease"

Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Tulane University School of Public Health and Tropical Medicine
Sponsor:
Collaborators:
Institute for Clinical Effectiveness and Health Policy
Laboratory of Parasitology Universite Libre de Bruxelles
Inst de Enfermedades Infecciosas y Parasitol Antonio Vidal
Lab de Parasitologia Universidad Autonoma de Yucatan
Information provided by (Responsible Party):
Dr. Pierre Buekens, Tulane University School of Public Health and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01787968
First received: February 7, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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.


Condition
Chagas Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

Resource links provided by NLM:


Further study details as provided by Tulane University School of Public Health and Tropical Medicine:

Primary Outcome Measures:
  • Congenital transmission of Trypanosoma cruzi [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Birth outcomes [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Plasma, blood with guanidine, dry spots on filter papers


Estimated Enrollment: 30500
Study Start Date: April 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women delivering in participating hospitals.

Criteria

Inclusion Criteria:

  • Women 18 years old or more, informed consent, live birth.

Exclusion Criteria:

  • Women residing outside of the follow-up area.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787968

Contacts
Contact: Pierre Buekens, MD, PhD 504-988-5397 pbuekens@tulane.edu

Locations
United States, Louisiana
Tulane School of Public Health and Tropical Medicine Active, not recruiting
New Orleans, Louisiana, United States, 70112
Argentina
Institute for Clinical Effectiveness and Health Policy Recruiting
Buenos Aires, Argentina
Contact: Fernando Althabe, MD, MSc       falthabe@gmail.com   
Principal Investigator: Fernando Althabe, MD, MSc         
Sub-Investigator: Jose Belizan, MD, PhD         
Sub-Investigator: Maria Luisa Cafferata, MD         
Sub-Investigator: Sergio Sosa-Estani, MD, PhD         
Belgium
Laboratory of Parasitology, Universite Libre de Bruxelles Active, not recruiting
Brussels, Belgium
Honduras
Inst. de Enfermedades Infecciosas y Parasitol Antonio Vidal Recruiting
Tegucigalpa, Honduras
Contact: Jackeline Alger, MD, PhD       jackelinealger@yahoo.es   
Principal Investigator: Jackeline Alger, MD, PhD         
Mexico
Lab. de Parasitologia, Universidad Autonoma de Yucatan Recruiting
Merida, Mexico
Contact: Eric Dumonteil, PhD       edumonte@tulane.edu   
Principal Investigator: Eric Dumonteil, PhD         
Sub-Investigator: Rubi Gamboa-Leon, MSc, PhD         
Sponsors and Collaborators
Tulane University School of Public Health and Tropical Medicine
Institute for Clinical Effectiveness and Health Policy
Laboratory of Parasitology Universite Libre de Bruxelles
Inst de Enfermedades Infecciosas y Parasitol Antonio Vidal
Lab de Parasitologia Universidad Autonoma de Yucatan
Investigators
Study Director: Jackeline Alger, MD, PhD Inst de Enfermedades Infecciosas y Parasitol Antonio Vidal
Study Director: Eric Dumonteil, PhD Lab de Parasitologia Universidad Autonoma de Yucatan
Study Director: Yves Carlier, MD, PhD Laboratory of Parasitology Universite Libre de Bruxelles
Study Director: Fernando Althabe, MD, MSc Institute for Clinical Effectiveness and Health Policy
  More Information

Additional Information:
No publications provided by Tulane University School of Public Health and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Pierre Buekens, W.H. Watkins Professor and Dean, Tulane University School of Public Health and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01787968     History of Changes
Other Study ID Numbers: R01AI083563
Study First Received: February 7, 2013
Last Updated: February 7, 2013
Health Authority: United States: National Institutes of Health

Keywords provided by Tulane University School of Public Health and Tropical Medicine:
Congenital transmission
Trypanosoma cruzi
Chagas disease

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 30, 2014