Clinical trial NCT05908682: Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Official title: A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vulvovaginal Candidiasis
Candida Infection
Vaginal Candidiasis
Keywords: VVC
Thrush
BREXAFEMME
Candidiasis
Vaginal Yeast
Yeast Infection
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AWINSA
First posted: 2023-06-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include women who were exposed to ibrexafungerp at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, volunteering to take part in this study.

Brief summary: This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.

Detailed description: This is a single-arm safety study which comprises an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age who were exposed to ibrexafungerp during pregnancy, or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, and are volunteering to take part in this study. Subjects will be monitored starting from exposure during pregnancy until one year after live delivery.

Information on pregnancy outcomes and complications as well as fetal/neonatal/infant outcomes will be collected during the timeframe described in the protocol.

Subjects can enroll in the study by calling the telephone number directly (1-888-982-7299) or through SCYNEXIS BREXAFEMME Pregnancy Study Webpage, OR her healthcare provider (HCP) can, with her consent, enroll her on her behalf.

Data will be collected both retrospectively and prospectively using a variety of questionnaire that will be completed by the representative based on interview with the subject and/or HCP

Eligibility criteria: Inclusion Criteria:

1. Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp
2. Subject and/or parent/legal representative consents to participate and agrees to the conditions and requirements of the study including the interview schedule/completion of questionnaire and release of medical records

   * Subject can be identified by the sponsor or HCP, in terms of confirmed pregnancy.

A self-reported pregnancy will be considered as confirmed pregnancy if the Urine Pregnancy Test (UPT) result is positive.

* A woman can self-enroll in the study or her healthcare provider (HCP), with her consent, can enroll her on her behalf.

Exclusion Criteria:

1. Females who were not exposed to safety study medications during pregnancy
2. Refusal to participate in the study
3. An inability to provide an accurate medical history or give informed consent

Primary outcomes:
measure: Major Structural Defects
timeFrame: From Brexafemme exposure up to one year after birth
Secondary outcomes:
measure: To collect and describe pregnancy outcomes
timeFrame: From Brexafemme exposure up to one year post birth
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AWINSA
state: Vasant Vihar
Study officials:
References: