Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT05285735
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2022-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
Sponsor:
Amivas Inc.
Organization:
Study Overview
Official Title:
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective observational study in which a female patient who received IV Artesunate while pregnant can volunteer to provide information about her pregnancy and the outcome of her pregnancy. Information will be collected from patient's provider, the patient's obstetrician, the child's pediatrician, or other relevant healthcare provider.
Detailed Description:
Pregnant women or physicians treating pregnant women with severe malaria with IV Artesunate will become aware of the Pregnancy Registry via the product label, the Amivas Inc. website, or her physician. By calling 1-855-526-4827 (1-855-5AMIVAS) or contacting www.amivas.com/our-products, the patient or physician will be connected to the Pregnancy Registry Call Center. In France, the Collaborating-Investigators conducting the ARTEMUM observatory study have a wide information campaign among obstetrical wards, neonatal wards, Infectious Diseases wards, intensive care units (ICU), and parasitology hospital laboratories, through expert networks of infectious diseases specialists, obstetricians and pediatricians in University hospitals from the Paris Area and suburbs that concentrate 50-55% of malaria cases in France. They also collaborate with the National Research Center (NRC) for malaria and will capture voluntary reports by clinicians and microbiologists in the NRC network.
When contact is made to the call center, a trained staff member will acquaint the patient or treating physician with the goals and procedures of the study. If the patient agrees to participate in the study over the telephone, the patient's verbal consent will be documented, and the patient will be sent the study Consent Form that includes the consent for the patient's physician/obstetrician and the child's pediatrician to release medical information via email. If a physician is contacting the Call Center, s/he may be provided with this form to review, and the physician will be directed to ask the patient to telephone the Call Center to provide consent. With the patient's consent, the patient's physician/obstetrician will be contacted by a Call Center staff member and will be interviewed by a trained call center healthcare professional/pharmacist for information about the patient including demographics, malaria history, history of treatment, and initial pregnancy data. The Call Center will contact the patient's physicians (including obstetrician and infant's pediatrician, as appropriate) each trimester until delivery, and also at birth and 1 year after birth, to collect data on maternal adverse events (AEs), pregnancy outcome, fetal outcome, and infant outcome. Patients consented in France under the ARTEMUM study will undergo the consent process by the treating Physician. Anonymized data will be prospectively collected by a research technician under the supervision of a local manager in France.
Data collected by the call center will be sent to the Coordinating Center on a monthly basis for review and tracking of participants, then annually for inclusion in the interim or final report. Data collected as part of the ARTEMUM study will be provided in aggregate as summary tables to be included in the annual report.
When contact is made to the call center, a trained staff member will acquaint the patient or treating physician with the goals and procedures of the study. If the patient agrees to participate in the study over the telephone, the patient's verbal consent will be documented, and the patient will be sent the study Consent Form that includes the consent for the patient's physician/obstetrician and the child's pediatrician to release medical information via email. If a physician is contacting the Call Center, s/he may be provided with this form to review, and the physician will be directed to ask the patient to telephone the Call Center to provide consent. With the patient's consent, the patient's physician/obstetrician will be contacted by a Call Center staff member and will be interviewed by a trained call center healthcare professional/pharmacist for information about the patient including demographics, malaria history, history of treatment, and initial pregnancy data. The Call Center will contact the patient's physicians (including obstetrician and infant's pediatrician, as appropriate) each trimester until delivery, and also at birth and 1 year after birth, to collect data on maternal adverse events (AEs), pregnancy outcome, fetal outcome, and infant outcome. Patients consented in France under the ARTEMUM study will undergo the consent process by the treating Physician. Anonymized data will be prospectively collected by a research technician under the supervision of a local manager in France.
Data collected by the call center will be sent to the Coordinating Center on a monthly basis for review and tracking of participants, then annually for inclusion in the interim or final report. Data collected as part of the ARTEMUM study will be provided in aggregate as summary tables to be included in the annual report.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: