deltatrials
Terminated PHASE2 INTERVENTIONAL 3-arm NCT03970200

Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)

A Phase II, Randomized Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Severe or Severe-Complicated/Fulminant Clostridium Difficile Infection

Sponsor: University of Pennsylvania

Conditions Severe Clostridium Difficile Infection Severe-Complicated/Fulminant Clostridium Difficile Infection
Interventions Antibiotics Penn Microbiome Therapy - 001 Penn Microbiome Therapy - 002 Penn Microbiome Therapy - 003
Updated 18 times since 2019 Last updated: Oct 27, 2023 Started: Jan 16, 2020 Primary completion: Nov 21, 2021 Completion: May 14, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Administrative reasons.

Other terminated trials from University of Pennsylvania

See all terminations from University of Pennsylvania

This PHASE2 trial investigates Severe Clostridium Difficile Infection and Severe-Complicated/Fulminant Clostridium Difficile Infection and is currently terminated or withdrawn. University of Pennsylvania leads this study, which shows 18 recorded versions since 2020 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Oct 2020 · 6 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Nov 2022 · 9 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Nov 2023 · 9 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Nov 2023 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Feb 2023 — Nov 2023 [monthly]

    Terminated PHASE2

  5. Dec 2022 — Feb 2023 [monthly]

    Terminated PHASE2

▶ Show 13 earlier versions

  1. Nov 2022 — Dec 2022 [monthly]

    Terminated PHASE2

    Status: Active Not Recruiting → Terminated

  2. Feb 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Sep 2021 — Feb 2022 [monthly]

    Recruiting PHASE2

  4. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  5. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  6. Apr 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  7. Feb 2020 — Apr 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  8. Jan 2020 — Feb 2020 [monthly]

    Not Yet Recruiting PHASE2

  9. Nov 2019 — Jan 2020 [monthly]

    Not Yet Recruiting PHASE2

  10. Sep 2019 — Nov 2019 [monthly]

    Not Yet Recruiting PHASE2

  11. Aug 2019 — Sep 2019 [monthly]

    Not Yet Recruiting PHASE2

  12. Jul 2019 — Aug 2019 [monthly]

    Not Yet Recruiting PHASE2

  13. Jun 2019 — Jul 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Pennsylvania
Data source: University of Pennsylvania

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

Study Locations