Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

NCT01787968 | Completed

• 1 other identifier: R01AI083563
• Study Type: observational
• Target: 28,348
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Chagas Disease

Keywords

Congenital transmission; Trypanosoma cruzi; Chagas disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Birth outcomes

  Two years

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women delivering in participating hospitals.

You may qualify if:

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

You may not qualify if:

• Women residing outside of the follow-up area.

Sponsors & Collaborators

• Tulane University School of Public Health and Tropical Medicine: lead
• Institute for Clinical Effectiveness and Health Policy: collaborator
• Université Libre de Bruxelles: collaborator
• Instituto de Enfermedades Infecciosas y Parasitol Antonio Vidal: collaborator
• Lab de Parasitologia Universidad Autonoma de Yucatan: collaborator

Study Sites (5)

Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location

Institute for Clinical Effectiveness and Health Policy

Buenos Aires, Argentina

Location

Laboratory of Parasitology, Universite Libre de Bruxelles

Brussels, Belgium

Location

Inst. de Enfermedades Infecciosas y Parasitol Antonio Vidal

Tegucigalpa, Honduras

Location

Lab. de Parasitologia, Universidad Autonoma de Yucatan

Mérida, Mexico

Location

Related Publications (1)

• 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.

  PMID: 24119247 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, blood with guanidine, dry spots on filter papers

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Pierre Buekens, MD, PhD

  Tulane SPHTM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: W.H. Watkins Professor and Dean

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 16, 2016

Record last verified: 2016-11

Locations

HO (1); US (1); BE (1); ME (1); AR (1)