deltatrials
Completed PHASE1 INTERVENTIONAL 3-arm NCT00538382

Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo

Phase I Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo

Sponsor: Bill and Melinda Gates Foundation

Conditions Malaria
Interventions Artesunate
Updated 8 times since 2017 Last updated: Jul 29, 2014 Started: May 31, 2007 Primary completion: Nov 30, 2008 Completion: Dec 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00538382, this PHASE1 trial focuses on Malaria and remains completed. Sponsored by Bill and Melinda Gates Foundation, it has been updated 8 times since 2007, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Sep 2020 · 27 months · monthly snapshotCompleted~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE1

Show 3 earlier versions
  1. Jun 2018 — Sep 2020 [monthly]

    Completed PHASE1

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

May 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bill and Melinda Gates Foundation
  • Fogarty International Center of the National Institute of Health
  • Global Network for Women's and Children's Health Research
  • Kinshasa School of Public Health
  • NICHD Global Network for Women's and Children's Health
  • National Cancer Institute (NCI)
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • RTI International
  • University of North Carolina
Data source: NICHD Global Network for Women's and Children's Health

For direct contact, visit the study record on ClinicalTrials.gov .