Not Yet Recruiting

Chagas disease

Bayer Identifier:

21944

ClinicalTrials.gov Identifier:

NCT05477953

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A

Trial summary

Enrollment Goal

Trial Dates

June 2025 - January 2032

Phase

Phase 4

Could I Receive a placebo

Products

Lampit (Nifurtimox, BAYA2502)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Not yet recruiting	Many Locations	Many Locations, Argentina
Not yet recruiting	Many Locations	Many Locations, 26505, United States
Not yet recruiting	Many Locations	Many Locations, Bolivia,plurinational State Of
Not yet recruiting	Many Locations	Many Locations, Chile
Not yet recruiting	Many Locations	Many Locations, Uruguay
Not yet recruiting	Many Locations	Many Locations, Germany
Not yet recruiting	Many Locations	Many Locations, Spain
Not yet recruiting	Many Locations	Many Locations, Guatemala
Not yet recruiting	Many Locations	Many Locations, El Salvador
Not yet recruiting	Many locations	Many locations, Honduras

Primary Outcome

Major Congenital Malformations (birth defects)
1. any major structural defect diagnosed with signs/symptoms, using the selected major congenital anomalies list extracted from the Birth defects surveillance: a manual, CDC. 2. 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.
Time Frame:
Up to pregnancy week 40

Secondary Outcome

Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness
Time Frame:
Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Medications
Time Frame:
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
Time Frame:
Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality
Time Frame:
Up to 12 months of age
Maternal Complications: Premature rupture of membranes (PROM)
Time Frame:
Up to pregnancy week 40
Maternal Complications: Preeclampsia
Time Frame:
Up to pregnancy week 40
Maternal Complications: Severe pregnancy-induced hypertension (PIH)
Time Frame:
Up to pregnancy week 40
Maternal Complications: Proteinuria
Time Frame:
Up to pregnancy week 40
Maternal Complications: Gestational diabetes
Time Frame:
Up to pregnancy week 40
Maternal Complications: Measures of fetal growth deficiency (small for gestational age)
Time Frame:
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.
Time Frame:
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.
Time Frame:
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.
Time Frame:
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).
Time Frame:
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).
Time Frame:
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 ).
Time Frame:
Up to pregnancy week 40

Trial design

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

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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