Actively Recruiting
A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
Led by Scynexis, Inc. · Updated on 2024-07-17
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Scynexis, Inc.
Lead Sponsor
A
AWINSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is an ongoing observational study evaluating the safety of ibrexafungerp exposure during pregnancy, focusing on pregnant women of any age. It aims to collect detailed information about pregnancy outcomes, complications, and infant health up to one year after live birth. The study is sponsored by Scynexis, Inc. and addresses concerns related to vulvovaginal candidiasis and other Candida infections. Participants include pregnant women exposed to ibrexafungerp during pregnancy or those whose conception occurred within four days after the last ibrexafungerp dose. This single-arm study is not interventional, meaning treatments are not assigned by the researchers. Data collection uses questionnaires completed through interviews with the participants or their healthcare providers, both retrospectively and prospectively. During the study, participants will be monitored from the time of exposure through pregnancy until one year after the infant's birth. Researchers will gather information on major structural defects and other pregnancy and infant outcomes. Participation involves completing interviews and questionnaires, releasing medical records, and ongoing follow-up to assess health outcomes related to ibrexafungerp exposure.
CONDITIONS
Brief Title
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Exposure to ibrexafungerp during pregnancy or conception estimated within 4 days after last dose
- Subject or parent/legal representative consents to participate and agrees to study requirements including interviews and medical record release
- Pregnancy can be confirmed by healthcare provider or a positive urine pregnancy test
- Subjects can self-enroll or be enrolled by healthcare provider with consent
You will not qualify if you...
- Females not exposed to ibrexafungerp during pregnancy
- Refusal to participate in the study
- Inability to provide accurate medical history or give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (phone or in-person)
Duration - From exposure during pregnancy until one year after live delivery
Participants who were exposed to ibrexafungerp during pregnancy are observed for pregnancy outcomes and infant health.
Periodic interviews and medical record collection throughout pregnancy and up to one year after birth
Trial Site Locations
Total: 1 location
1
AWINSA
New Delhi, Vasant Vihar, India, 110057
Actively Recruiting
Research Team
S
Sanjeev Miglani, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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