deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00550732

A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2) (TIP)

A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The TIP Study.

Sponsor: JSS Medical Research Inc.

Conditions Mycoses
Interventions Posaconazole
Updated 7 times since 2017 Last updated: Mar 9, 2017 Started: Dec 31, 2007 Primary completion: Nov 30, 2012 Completion: Nov 30, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Mycoses, this trial is completed. The trial is conducted by JSS Medical Research Inc. and has accumulated 7 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

In the past two decades, invasive fungal infections (IFI) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with IFI. Over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. This has demonstrated the need for the development of a new generation of azoles.

In the past two decades, invasive fungal infections (IFI) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with IFI. Over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. This has demonstrated the need for the development of a new generation of azoles.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshotCompleted~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jun 2022 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Dec 2007

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • JSS Medical Research Inc.
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

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

Study Locations

No location information available.