Status:
RECRUITING
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
Lead Sponsor:
Amivas Inc.
Conditions:
Pregnancy
Malaria
Eligibility:
FEMALE
15-100 years
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 preg...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05285735
Start Date
June 8 2022
End Date
July 1 2029
Last Update
January 30 2024
Active Locations (1)
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1
4C Pharma Solutions
Piscataway, New Jersey, United States, 08854