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Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

NCT ID: NCT01787968

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chagas Disease

Keywords

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Congenital transmission Trypanosoma cruzi Chagas disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Women residing outside of the follow-up area.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institute for Clinical Effectiveness and Health Policy

OTHER

Sponsor Role collaborator

Laboratory of Parasitology Universite Libre de Bruxelles

UNKNOWN

Sponsor Role collaborator

Instituto de Enfermedades Infecciosas y Parasitol Antonio Vidal

UNKNOWN

Sponsor Role collaborator

Lab de Parasitologia Universidad Autonoma de Yucatan

UNKNOWN

Sponsor Role collaborator

Tulane University School of Public Health and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Dr. Pierre Buekens

W.H. Watkins Professor and Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Buekens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tulane SPHTM

Locations

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Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, United States

Site Status

Institute for Clinical Effectiveness and Health Policy

Buenos Aires, , Argentina

Site Status

Laboratory of Parasitology, Universite Libre de Bruxelles

Brussels, , Belgium

Site Status

Inst. de Enfermedades Infecciosas y Parasitol Antonio Vidal

Tegucigalpa, , Honduras

Site Status

Lab. de Parasitologia, Universidad Autonoma de Yucatan

Mérida, , Mexico

Site Status

Countries

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United States Argentina Belgium Honduras Mexico

References

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Buekens P, Cafferata ML, Alger J, Althabe F, Belizan JM, Carlier Y, Ciganda A, Dumonteil E, Gamboa-Leon R, Howard E, Matute ML, Sosa-Estani S, Truyens C, Wesson D, Zuniga C. Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol. Reprod Health. 2013 Oct 11;10:55. doi: 10.1186/1742-4755-10-55.

Reference Type DERIVED
PMID: 24119247 (View on PubMed)

Related Links

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http://www.chagascongenito.info/

Related Info

Other Identifiers

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R01AI083563

Identifier Type: NIH

Identifier Source: org_study_id

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