Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

Chagas Disease Clinical Trial

Official title:

Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787968
• Other study ID #: R01AI083563
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: November 15, 2016
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28348
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women residing outside of the follow-up area.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chagas Disease

Locations

Country	Name	City	State
Argentina	Institute for Clinical Effectiveness and Health Policy	Buenos Aires
Belgium	Laboratory of Parasitology, Universite Libre de Bruxelles	Brussels
Honduras	Inst. de Enfermedades Infecciosas y Parasitol Antonio Vidal	Tegucigalpa
Mexico	Lab. de Parasitologia, Universidad Autonoma de Yucatan	Merida
United States	Tulane School of Public Health and Tropical Medicine	New Orleans	Louisiana

Sponsors (5)

Lead Sponsor	Collaborator
Tulane University School of Public Health and Tropical Medicine	Institute for Clinical Effectiveness and Health Policy, Instituto de Enfermedades Infecciosas y Parasitol Antonio Vidal, Lab de Parasitologia Universidad Autonoma de Yucatan, Laboratory of Parasitology Universite Libre de Bruxelles

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Honduras,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Congenital transmission of Trypanosoma cruzi	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.	Two years	No
Secondary	Birth outcomes	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.	Two years	No

External Links

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