Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants

Pregnancy Clinical Trial

Official title:

Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285735
• Other study ID #: IVAS 3851-1
• Status: Recruiting
• Start date: June 8, 2022
• Est. completion date: July 1, 2029

Study information

• Verified date: January 2024
• Source: Amivas (US), LLC
• Contact: Katrina Riggs
• Phone: 3017622609
• Email: kriggs[@]fastttrackresearch.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 1, 2029
• Est. primary completion date: June 8, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patient received IV Artesunate

• Patient was pregnant while receiving IV Artesunate

• Patient was at least 15 years of age

• Patient or legal guardian/representative gave consent for the study and to collect data from her physicians

Exclusion Criteria

• None

Related Conditions & MeSH terms

• Malaria
• Pregnancy

Locations

Country	Name	City	State
United States	4C Pharma Solutions	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Amivas (US), LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pregnant females with high blood pressure	Number of pregnant females with high blood pressure reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with severe nausea	Number of pregnant females with severe nausea reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with vomiting	Number of pregnant females with vomiting reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with dehydration	Number of pregnant females with dehydration reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with diabetes (newly occurring)	Number of pregnant females with diabetes (newly occurring) reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with obesity/marked weight gain	Number of pregnant females with obesity/marked weight gain reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with anemia (newly occurring)	Number of pregnant females with anemia (newly occurring) reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with kidney or bladder infections	Number of pregnant females with kidney or bladder infections reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with vaginal bleeding	Number of pregnant females with vaginal bleeding reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with abruptio placenta	Number of pregnant females with abruptio placenta reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with placenta previa	Number of pregnant females with placenta previa reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with premature rupture of membranes	Number of pregnant females with premature rupture of membranes reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with preterm labor	Number of pregnant females with preterm labor reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with ectopic pregnancy	Number of pregnant females with ectopic pregnancy reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with molar pregnancy	Number of pregnant females with molar pregnancy reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females who died	Number of pregnant females who died reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with spontaneous abortions/miscarriage	Number of pregnant females with spontaneous abortions/miscarriage reported in medical record	Up to 20 weeks
Primary	Number of pregnant females with elective terminations	Number of pregnant females with elective terminations reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of fetal deaths/stillbirths	Number of fetal deaths/stillbirths reported in medical record	From 20 weeks to study completion
Primary	Number of premature live births (<37 weeks)	Number of premature live births (<37 weeks) reported in medical record	Up to 37 weeks
Primary	Number pregnant females with with live term births	Number pregnant females with with live term births reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of pregnant females with normal vaginal delivery or C-section	Number of pregnant females with normal vaginal delivery or C-section reported in medical record	Through study completion, an average of 40 weeks
Primary	Number of newborns with low birth weight (<2500 grams)	Number of newborns with low birth weight (<2500 grams)	At birth
Primary	Number of newborns with heart and circulation defects	Number of newborns with heart and circulation defects reported in medical record	At birth
Primary	Number of newborns with genital and urinary tract defects	Number of newborns with genital and urinary tract defects reported in medical record	At birth
Primary	Number of newborns with nervous system and eye defects	Number of newborns with nervous system and eye defects reported in medical record	At birth
Primary	Number of newborns with Club foot	Number of newborns with Club foot reported in medical record	At birth
Primary	Neonate mean body weight (kg)	Neonate mean body weight (kg)	1 month
Primary	Infant mean body weight (kg)	Infant mean body weight (kg)	12 months
Primary	Number of infants who sit unattended or without support	Number of infants who sit unattended or without support from medical record	12 months
Primary	Number of infants who pick up small objects with thumb-finger grasp	Number of infants who pick up small objects with thumb-finger grasp from medical record	12 months
Primary	Number of infants who say "Dada" or "Mama" nonspecifically	Number of infants who say "Dada" or "Mama" nonspecifically from medical record	12 months
Primary	Number of infants who look for dropped objects or objects hidden by parents	Number of infants who look for dropped objects or objects hidden by parents from medical record	12 months
Primary	Neonate mean body length (cm)	Neonate mean body length (cm)	1 month
Primary	Neonate mean head circumference (cm)	Neonate mean head circumference (cm)	1 month
Primary	Infant mean recumbent weight (kg)	Infant mean recumbent weight (kg)	12 months
Primary	Infant mean weight-for-length ratio (kg/cm)	Infant mean weight (kg) divided by body length (cm)	12 months