Observing the safety of IV Artesunate treatment in pregnant women and their infants
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
This study is trying to see if IV Artesunate treatment is safe for pregnant women with severe malaria and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 15 Years to 100 Years |
| Sex | Female |
| Sponsor | Amivas Inc. Industry-sponsored |
| Locations | 1 site (Piscataway, New Jersey) |
| Trial ID | NCT05285735 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the safety of intravenous Artesunate treatment in pregnant women diagnosed with severe malaria. Participants will voluntarily provide information about their pregnancy and its outcomes, with data collected from healthcare providers including obstetricians and pediatricians. The study is facilitated through a Pregnancy Registry, where patients or their physicians can connect via a dedicated call center. The initiative includes collaboration with various medical professionals and institutions to ensure comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 15 and older who have received IV Artesunate for severe malaria.
Not a fit: Patients who have not received IV Artesunate during pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the safety of IV Artesunate in pregnant women, potentially improving treatment protocols for malaria during pregnancy.
How similar studies have performed: While this study is observational and focuses on a specific treatment, similar approaches in monitoring drug safety during pregnancy have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Piscataway, New Jersey
- 4C Pharma Solutions — Piscataway, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Bryan Smith, MD — Amivas Inc.
- Study coordinator: Katrina Riggs
- Email: kriggs@fastttrackresearch.com
- Phone: 3017622609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.