Chagas DiseaseNCT05477953
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
An observational study of Chagas Disease, run by Bayer at 12 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Nifurtimox (BAYA2502)
- How many people
- 50 participants
- Where
- 12 sitesin 12 countries
- Study dates
- 31 Dec 2026to 31 Jan 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
12 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 12 countries
United States1 site
Many Locations
Multiple Locations, West Virginia, 26505
About this study
Official title: 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.
Read more
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.
- Conditions
- Chagas Disease
- Being tested
- Nifurtimox (BAYA2502)
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifurtimox (BAYA2502)Drug
At least 1 dose of nifurtimox
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nifurtimox (BAYA2502) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to pregnancy week 40
Secondary outcomes (16)
Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness
Measured: Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Medications
Measured: 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
Measured: Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality
Measured: Up to 12 months of age
Maternal Complications: Premature rupture of membranes (PROM)
Measured: Up to pregnancy week 40
Maternal Complications: Preeclampsia
Measured: Up to pregnancy week 40
Maternal Complications: Severe pregnancy-induced hypertension (PIH)
Measured: Up to pregnancy week 40
Maternal Complications: Proteinuria
Measured: Up to pregnancy week 40
Maternal Complications: Gestational diabetes
Measured: Up to pregnancy week 40
Maternal Complications: Measures of fetal growth deficiency (small for gestational age)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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 ).
Measured: Up to pregnancy week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start31 Dec 2026 (estimated)
- Primary completion31 Jan 2032 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477953
- Sponsor's protocol ID
- 21944
- Status last verified
- Jul 2026
- First submitted
- 19 May 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.