deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT03388268

TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment

Double Blinded, Randomized Controlled Trial of Oral Vancomycin Versus Placebo in Hospitalized Patients With Diarrhea and Stool toXin NEGative But Nucleic Acid Amplification Test Positive for Toxigenic Clostridium Difficile (TOX NEG Trial)

Sponsor: Washington University School of Medicine

Conditions Clostridium Difficile Infection Diarrhea
Interventions Nuceleic acid amplification test Oral Vancomycin Placebo Toxin enzyme immunoassay
Updated 15 times since 2018 Last updated: Jul 22, 2021 Started: Dec 29, 2017 Primary completion: Jan 31, 2021 Completion: Jan 31, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03388268, this PHASE4 trial focuses on Clostridium Difficile Infection and Diarrhea and remains completed. Sponsored by Washington University School of Medicine, it has been updated 15 times since 2017, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshot~Jun 2019 – ~Feb 2020 · 8 months · monthly snapshot~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshot~Jun 2020 – ~Nov 2020 · 5 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Dec 2022 · 15 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE4

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE4

▶ Show 10 earlier versions

  1. Sep 2021 — Dec 2022 [monthly]

    Completed PHASE4

    Status: Active Not Recruiting → Completed

  2. Mar 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE4

  3. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE4

  4. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE4

  5. Jun 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE4

    Status: Enrolling By Invitation → Active Not Recruiting

  6. Feb 2020 — Jun 2020 [monthly]

    Enrolling By Invitation PHASE4

  7. Jun 2019 — Feb 2020 [monthly]

    Enrolling By Invitation PHASE4

  8. Jun 2018 — Jun 2019 [monthly]

    Enrolling By Invitation PHASE4

  9. Feb 2018 — Jun 2018 [monthly]

    Enrolling By Invitation PHASE4

  10. Jan 2018 — Feb 2018 [monthly]

    Enrolling By Invitation PHASE4

    First recorded

Dec 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Washington University School of Medicine
Data source: Washington University School of Medicine

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

Study Locations