PregnancyNCT05285735
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
An observational study of Pregnancy and Malaria, run by Amivas Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 100 years, women only
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 1 Jul 2029
- How long will I take part?
- 21 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
4C Pharma Solutions
Piscataway, New Jersey, 08854
Ankur Joshi, 732-529-6989, ankur.joshi@4cpharma.com
About this study
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.
Read the 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.
- Keywords
- Artesunate, Pregnancy Registry
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pregnant females with high blood pressure
Number of pregnant females with high blood pressure reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with severe nausea
Number of pregnant females with severe nausea reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with vomiting
Number of pregnant females with vomiting reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with dehydration
Number of pregnant females with dehydration reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with diabetes (newly occurring)
Number of pregnant females with diabetes (newly occurring) reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with obesity/marked weight gain
Number of pregnant females with obesity/marked weight gain reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with anemia (newly occurring)
Number of pregnant females with anemia (newly occurring) reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with kidney or bladder infections
Number of pregnant females with kidney or bladder infections reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with vaginal bleeding
Number of pregnant females with vaginal bleeding reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with abruptio placenta
Number of pregnant females with abruptio placenta reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with placenta previa
Number of pregnant females with placenta previa reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with premature rupture of membranes
Number of pregnant females with premature rupture of membranes reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with preterm labor
Number of pregnant females with preterm labor reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with ectopic pregnancy
Number of pregnant females with ectopic pregnancy reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with molar pregnancy
Number of pregnant females with molar pregnancy reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females who died
Number of pregnant females who died reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of pregnant females with spontaneous abortions/miscarriage
Number of pregnant females with spontaneous abortions/miscarriage reported in medical record
Measured: Up to 20 weeks
Number of pregnant females with elective terminations
Number of pregnant females with elective terminations reported in medical record
Measured: Through study completion, an average of 40 weeks
Number of fetal deaths/stillbirths
Number of fetal deaths/stillbirths reported in medical record
Measured: From 20 weeks to study completion
Number of premature live births (<37 weeks)
Number of premature live births (<37 weeks) reported in medical record
Measured: Up to 37 weeks
Number pregnant females with with live term births
Number pregnant females with with live term births reported in medical record
Measured: Through study completion, an average of 40 weeks
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
Measured: Through study completion, an average of 40 weeks
Number of newborns with low birth weight (<2500 grams)
Number of newborns with low birth weight (<2500 grams)
Measured: At birth
Number of newborns with heart and circulation defects
Number of newborns with heart and circulation defects reported in medical record
Measured: At birth
Number of newborns with genital and urinary tract defects
Number of newborns with genital and urinary tract defects reported in medical record
Measured: At birth
Number of newborns with nervous system and eye defects
Number of newborns with nervous system and eye defects reported in medical record
Measured: At birth
Number of newborns with Club foot
Number of newborns with Club foot reported in medical record
Measured: At birth
Neonate mean body weight (kg)
Neonate mean body weight (kg)
Measured: 1 month
Infant mean body weight (kg)
Infant mean body weight (kg)
Measured: 12 months
Number of infants who sit unattended or without support
Number of infants who sit unattended or without support from medical record
Measured: 12 months
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
Measured: 12 months
Number of infants who say "Dada" or "Mama" nonspecifically
Number of infants who say "Dada" or "Mama" nonspecifically from medical record
Measured: 12 months
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
Measured: 12 months
Neonate mean body length (cm)
Neonate mean body length (cm)
Measured: 1 month
Neonate mean head circumference (cm)
Neonate mean head circumference (cm)
Measured: 1 month
Infant mean recumbent weight (kg)
Infant mean recumbent weight (kg)
Measured: 12 months
Infant mean weight-for-length ratio (kg/cm)
Infant mean weight (kg) divided by body length (cm)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start8 Jun 2022
- Primary completion8 Jun 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Amivas Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Smith, MD, Principal investigator, Amivas Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285735
- Sponsor's protocol ID
- IVAS 3851-1
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
- ClinicalTrials.gov ID
- NCT05285735
- Acronym / sponsor ID
- IVAS 3851-1
- Keywords
- Artesunate, Pregnancy Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Amivas Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 8 Jun 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 21 Months
Who may qualify
- Ages
- 15 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of pregnant females with high blood pressure
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with high blood pressure reported in medical record
Number of pregnant females with severe nausea
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with severe nausea reported in medical record
Number of pregnant females with vomiting
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with vomiting reported in medical record
Number of pregnant females with dehydration
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with dehydration reported in medical record
Number of pregnant females with diabetes (newly occurring)
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with diabetes (newly occurring) reported in medical record
Number of pregnant females with obesity/marked weight gain
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with obesity/marked weight gain reported in medical record
Number of pregnant females with anemia (newly occurring)
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with anemia (newly occurring) reported in medical record
Number of pregnant females with kidney or bladder infections
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with kidney or bladder infections reported in medical record
Number of pregnant females with vaginal bleeding
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with vaginal bleeding reported in medical record
Number of pregnant females with abruptio placenta
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with abruptio placenta reported in medical record
Number of pregnant females with placenta previa
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with placenta previa reported in medical record
Number of pregnant females with premature rupture of membranes
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with premature rupture of membranes reported in medical record
Number of pregnant females with preterm labor
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with preterm labor reported in medical record
Number of pregnant females with ectopic pregnancy
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with ectopic pregnancy reported in medical record
Number of pregnant females with molar pregnancy
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with molar pregnancy reported in medical record
Number of pregnant females who died
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females who died reported in medical record
Number of pregnant females with spontaneous abortions/miscarriage
Time frame: Up to 20 weeks
Number of pregnant females with spontaneous abortions/miscarriage reported in medical record
Number of pregnant females with elective terminations
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with elective terminations reported in medical record
Number of fetal deaths/stillbirths
Time frame: From 20 weeks to study completion
Number of fetal deaths/stillbirths reported in medical record
Number of premature live births (<37 weeks)
Time frame: Up to 37 weeks
Number of premature live births (<37 weeks) reported in medical record
Number pregnant females with with live term births
Time frame: Through study completion, an average of 40 weeks
Number pregnant females with with live term births reported in medical record
Number of pregnant females with normal vaginal delivery or C-section
Time frame: Through study completion, an average of 40 weeks
Number of pregnant females with normal vaginal delivery or C-section reported in medical record
Number of newborns with low birth weight (<2500 grams)
Time frame: At birth
Number of newborns with low birth weight (<2500 grams)
Number of newborns with heart and circulation defects
Time frame: At birth
Number of newborns with heart and circulation defects reported in medical record
Number of newborns with genital and urinary tract defects
Time frame: At birth
Number of newborns with genital and urinary tract defects reported in medical record
Number of newborns with nervous system and eye defects
Time frame: At birth
Number of newborns with nervous system and eye defects reported in medical record
Number of newborns with Club foot
Time frame: At birth
Number of newborns with Club foot reported in medical record
Neonate mean body weight (kg)
Time frame: 1 month
Neonate mean body weight (kg)
Infant mean body weight (kg)
Time frame: 12 months
Infant mean body weight (kg)
Number of infants who sit unattended or without support
Time frame: 12 months
Number of infants who sit unattended or without support from medical record
Number of infants who pick up small objects with thumb-finger grasp
Time frame: 12 months
Number of infants who pick up small objects with thumb-finger grasp from medical record
Number of infants who say "Dada" or "Mama" nonspecifically
Time frame: 12 months
Number of infants who say "Dada" or "Mama" nonspecifically from medical record
Number of infants who look for dropped objects or objects hidden by parents
Time frame: 12 months
Number of infants who look for dropped objects or objects hidden by parents from medical record
Neonate mean body length (cm)
Time frame: 1 month
Neonate mean body length (cm)
Neonate mean head circumference (cm)
Time frame: 1 month
Neonate mean head circumference (cm)
Infant mean recumbent weight (kg)
Time frame: 12 months
Infant mean recumbent weight (kg)
Infant mean weight-for-length ratio (kg/cm)
Time frame: 12 months
Infant mean weight (kg) divided by body length (cm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan Smith, MD principal investigator
Amivas Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Malaria, run by Amivas Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrina Riggs (3017622609, kriggs@fastttrackresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pregnant females with high blood pressure (time frame: Through study completion, an average of 40 weeks). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.