Clinical trial Recruiting at 1 site Observational Ages 15 to 100 Women only

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.

More Pregnancy trials

Quick facts

Study typeObservational
Ages15 Years to 100 Years
SexWomen only
Enrollment25 (estimated)
SponsorAmivas Inc.
Industry-sponsored
Locations1 site (Piscataway, New Jersey)
StatusRecruiting
StartedJune 8, 2022
Main results expectedJune 8, 2029
Study endsJuly 1, 2029
Registry record updatedJanuary 30, 2024
Trial IDNCT05285735 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.