Observing the safety of IV Artesunate treatment in pregnant women and their infants
Official title: Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
Run by Amivas Inc. · NCT05285735 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 15 Years to 100 Years |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Amivas Inc. Industry-sponsored |
| Locations | 1 site (Piscataway, New Jersey) |
| Status | Recruiting |
| Started | June 8, 2022 |
| Main results expected | June 8, 2029 |
| Study ends | July 1, 2029 |
| Registry record updated | January 30, 2024 |
| Trial ID | NCT05285735 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 15 and older who have received IV Artesunate for severe malaria.
✕Probably not a fit
Patients who have not received IV Artesunate during pregnancy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.