deltatrials
Terminated PHASE1 INTERVENTIONAL 1-arm NCT05534529

Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age

A Phase 1, Multicentre, Open-Label Study to Evaluate the PK, Safety, and Tolerability of a Single IV Dose of Rezafungin in Paediatric Subjects, Receiving Systemic Antifungals as Prophylaxis for IFI or to Treat a Suspected or Confirmed FI

Sponsor: Mundipharma Research Limited

Interventions Rezafungin Acetate
Updated 7 times since 2022 Last updated: Apr 2, 2025 Started: Sep 13, 2023 Primary completion: May 23, 2024 Completion: Oct 14, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study had initially anticipated dosing of the first cohort within 4-9 months of activation; however the study faced significant challenges in recruitment. In order to adhere to the previously approved PIP plan, the study could not be redesigned.

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This PHASE1 trial investigates Invasive Fungal Infections and is currently terminated or withdrawn. Mundipharma Research Limited leads this study, which shows 7 recorded versions since 2023 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Sep 2022 – ~May 2023 · 8 months · monthly snapshotNot Yet Recruiting~May 2023 – ~Sep 2023 · 4 months · monthly snapshotNot Yet Recruiting~Sep 2023 – ~Jan 2024 · 4 months · monthly snapshotNot Yet Recruiting~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshotSuspended~May 2025 – present · 14 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. May 2025 — Present [monthly]

    Terminated PHASE1

    Status: SuspendedTerminated

  2. Sep 2024 — May 2025 [monthly]

    Suspended PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Suspended PHASE1

    Status: RecruitingSuspended

  4. Jan 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  5. Sep 2023 — Jan 2024 [monthly]

    Not Yet Recruiting PHASE1

Show 2 earlier versions
  1. May 2023 — Sep 2023 [monthly]

    Not Yet Recruiting PHASE1

  2. Sep 2022 — May 2023 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mundipharma Research Limited
Data source: Mundipharma Research Limited

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