An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health

Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.

Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems.

Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults.

It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans.

In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information:

• Birth defects (abnormal and problematic structures or functions, a child is born with)
• Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion)
• Certain health problems of the child up to 12 months of age
• Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population.

The study will run for approximately 10 years.

Study Overview

• Status: Not yet recruiting
• Conditions: Chagas Disease
• Intervention / Treatment: Drug: Nifurtimox (BAYA2502)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Argentina
  • Multiple Locations, Argentina
    • Many Locations
• Bolivia
  • Multiple Locations, Bolivia
    • Many Locations
• Chile
  • Multiple Locations, Chile
    • Many Locations
• El Salvador
  • Multiple Locations, El Salvador
    • Many Locations
• Germany
  • Multiple Locations, Germany
    • Many Locations
• Guatemala
  • Multiple Locations, Guatemala
    • Many Locations
• Honduras
  • Multiple Locations, Honduras
    • Many Locations
• Spain
  • Multiple Locations, Spain
    • Many Locations
• United States
  • West Virginia
    • Multiple Locations, West Virginia, United States, 26505
      • Many Locations
• Uruguay
  • Multiple Locations, Uruguay
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will actively pursue and attempt to capture all nifurtimox exposures during pregnancy that occur in all countries where nifurtimox is approved to be marketed by Bayer.

Description

Inclusion Criteria:

• Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period / time of conception to pregnancy outcome).
• Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent/legal guardian).

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women exposed to nifurtimox; The study will examine the effects of nifurtimox on fetuses, neonates and infants through 12 months of age who were exposed to nifurtimox in utero and maternal complications of pregnancy in women who were exposed to at least one dose of nifurtimox during pregnancy.	Drug: Nifurtimox (BAYA2502); At least 1 dose of nifurtimox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Congenital Malformations (birth defects)	any major structural defect diagnosed with signs/symptoms, using the selected major congenital anomalies list extracted from the Birth defects surveillance: a manual, CDC.; on a case-by-case basis, through evaluator review and agreement from external advisors (if required), any structural defect (that satisfy criterion 1 or 2) detected in the prenatal evaluation of a pregnancy or in the gross or pathologic examination of an abortus, fetus, or deceased infant will be included, if available, to increase the sensitivity of pregnancy study monitoring.	Up to pregnancy week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness		Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Medications		Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Growth and development milestones	Apgar Scale, CDC Growth Calculators, Cognitive Checklists, ASD (autism spectrum disorder) Tool	Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality		Up to 12 months of age
Maternal Complications: Premature rupture of membranes (PROM)		Up to pregnancy week 40
Maternal Complications: Preeclampsia		Up to pregnancy week 40
Maternal Complications: Severe pregnancy-induced hypertension (PIH)		Up to pregnancy week 40
Maternal Complications: Proteinuria		Up to pregnancy week 40
Maternal Complications: Gestational diabetes		Up to pregnancy week 40
Maternal Complications: Measures of fetal growth deficiency (small for gestational age)		Up to pregnancy week 40
Spontaneous abortion	Any loss of a fetus due to natural causes less than 20 weeks gestation as a spontaneous abortion (WHO/CDC/ICBDSR, 2014). If available, data from gross or pathological examination of the abortus or fetus will be evaluated for structural defects.	Up to 20 weeks
Elective/Induced abortion	Elective or induced abortion is the termination of pregnancy through medical or surgical procedures (ACOG, 2014) (WHO, 2014) If available, data from gross or pathological examination of the abortus or fetus will be evaluated for structural defects.	Up to pregnancy week 40
Fetal death/Still birth	Fetal death or stillbirth refers to fetuses born dead at > 20 weeks gestation or weighing > 500 grams. Fetal death occurring > 20 weeks but less than 28 weeks gestation is considered an early fetal loss. Fetal death occurring > 28 weeks is considered a late fetal loss (ACOG, 2014). If available, data from gross or pathological examination of the abortus or fetus will be evaluated for structural defects. • The study will make the final classification between fetal death/still birth and spontaneous abortion based on gestational age and weight. If these parameters are not available, the study will accept the classification indicated by the HCP.	More than 20 weeks gestation or weighing less than 500 grams
Preterm delivery	Births delivered prior to 37 completed weeks of gestation per 100 births. Gestational age is based on the obstetric estimate of gestation (CDC).	Prior to 37 completed weeks of gestation
Live Birth	A live birth refers to a complete expulsion from its mother of a surviving neonate breathing or showing any evidence of life such as a heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord has been cut or the placenta is attached (WHO, 2014).	Up to pregnancy week 40
Ectopic or Molar Pregnancy	Any reported ectopic or molar pregnancy will be sub-classified in the respective pregnancy outcome including induced abortion, live birth, or spontaneous pregnancy loss. CDC National Center for Health Statistics surveillance system (NCHS, 2004 ).	Up to pregnancy week 40

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): January 31, 2032
• Study Completion (Estimated): January 31, 2032

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Chagas Disease; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Trypanocidal Agents; Nifurtimox
• Other Study ID Numbers: 21944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No