RECRUITING

Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants

Quick Facts

Study Start:2022-06-08
Study Completion:2029-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05285735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient received IV Artesunate
  2. * Patient was pregnant while receiving IV Artesunate
  3. * Patient was at least 15 years of age
  4. * Patient or legal guardian/representative gave consent for the study and to collect data from her physicians
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Katrina Riggs
CONTACT
3017622609
kriggs@fastttrackresearch.com

Principal Investigator

Bryan Smith, MD
PRINCIPAL_INVESTIGATOR
Amivas (US), LLC

Study Locations (Sites)

4C Pharma Solutions
Piscataway, New Jersey, 08854
United States

Collaborators and Investigators

Sponsor: Amivas (US), LLC

  • Bryan Smith, MD, PRINCIPAL_INVESTIGATOR, Amivas (US), LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-08
Study Completion Date2029-07-01

Study Record Updates

Study Start Date2022-06-08
Study Completion Date2029-07-01

Terms related to this study

Keywords Provided by Researchers

  • Artesunate
  • Pregnancy Registry

Additional Relevant MeSH Terms

  • Pregnancy
  • Malaria