Clinical trial NCT05285735: Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
Official title: Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Malaria
Keywords: Artesunate
Pregnancy Registry
Lead sponsor: Amivas Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 25
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women worldwide who were or are being treated with IV Artesunate who can be properly consented to provide personal health information on her pregnancy and agree to provide health information on her fetus, neonate, and infant child will be included in the study. Although IV Artesunate is indicated for the treatment of severe malaria, women who were treated off label for another indication who received IV Artesunate while pregnant will be included in the study as well.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of pregnant females with high blood pressure
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with severe nausea
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with vomiting
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with dehydration
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with diabetes (newly occurring)
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with obesity/marked weight gain
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with anemia (newly occurring)
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with kidney or bladder infections
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with vaginal bleeding
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with abruptio placenta
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with placenta previa
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with premature rupture of membranes
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with preterm labor
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with ectopic pregnancy
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with molar pregnancy
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females who died
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with spontaneous abortions/miscarriage
timeFrame: Up to 20 weeks
measure: Number of pregnant females with elective terminations
timeFrame: Through study completion, an average of 40 weeks
measure: Number of fetal deaths/stillbirths
timeFrame: From 20 weeks to study completion
measure: Number of premature live births (<37 weeks)
timeFrame: Up to 37 weeks
measure: Number pregnant females with with live term births
timeFrame: Through study completion, an average of 40 weeks
measure: Number of pregnant females with normal vaginal delivery or C-section
timeFrame: Through study completion, an average of 40 weeks
measure: Number of newborns with low birth weight (<2500 grams)
timeFrame: At birth
measure: Number of newborns with heart and circulation defects
timeFrame: At birth
measure: Number of newborns with genital and urinary tract defects
timeFrame: At birth
measure: Number of newborns with nervous system and eye defects
timeFrame: At birth
measure: Number of newborns with Club foot
timeFrame: At birth
measure: Neonate mean body weight (kg)
timeFrame: 1 month
measure: Infant mean body weight (kg)
timeFrame: 12 months
measure: Number of infants who sit unattended or without support
timeFrame: 12 months
measure: Number of infants who pick up small objects with thumb-finger grasp
timeFrame: 12 months
measure: Number of infants who say "Dada" or "Mama" nonspecifically
timeFrame: 12 months
measure: Number of infants who look for dropped objects or objects hidden by parents
timeFrame: 12 months
measure: Neonate mean body length (cm)
timeFrame: 1 month
measure: Neonate mean head circumference (cm)
timeFrame: 1 month
measure: Infant mean recumbent weight (kg)
timeFrame: 12 months
measure: Infant mean weight-for-length ratio (kg/cm)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: 4C Pharma Solutions
state: New Jersey
Study officials:
affiliation: Amivas Inc.
name: Bryan Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: