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A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2) (TIP)
This study is ongoing, but not recruiting participants.

First Received on October 29, 2007.   Last Updated on July 20, 2011   History of Changes
Sponsor: Schering-Plough
Collaborator: JSS Medical Research Inc.
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00550732
  Purpose

The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early treatment of fungal infections in participants who are refractory to, intolerant to, or medically precluded from first-line monotherapy or first-line combination antifungal therapy.


Condition Intervention Phase
Mycoses
 Drug: posaconazole
 Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study.

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds
Drug Information available for: Posaconazole
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Proportion of participants with complete response (CR) or partial response (PR) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with ≥50% decrease in lesion size or number [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Time to response of target lesion [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Duration of clinical response in participants with CR or PR [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Number of participants with infection-free survival after the last dose of study drug [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: At 3 months and up to 6 months ] [ Designated as safety issue: No ]
  • Number of participants with response to posaconazole in combination therapy [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Number of participants experiencing adverse events (AEs) [ Time Frame: Baseline to study completion or participant discontinuation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posaconazole Drug: posaconazole
posaconazole oral suspension, 400 mg twice daily, or 200 mg 4 times daily for participants intolerant of food or nutritional supplements
Other Name: SCH056592

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proven or probable invasive fungal infection (IFI) including breakthrough infection while on antifungal treatment for at least 7 days.
  • Refractory or intolerant to prior antifungal therapy, or medically unable to receive standard antifungal therapy.
  • Age ≥13 years old.
  • Expected to survive >1 month.
  • Negative pregnancy test (serum or urine) at baseline for women of childbearing potential.

Exclusion Criteria:

  • Serum bilirubin >10 times upper limit of normal (ULN).
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >10 times ULN.
  • Documented allergy to azoles.
  • Unable to take oral suspension medications or enteral feeding.
  • Pregnant or breastfeeding.
  • Participants who have received an investigational drug are allowed to be enrolled if the investigational drug was given 30 days prior to study registration, unless approved by the Sponsor.
  • Requires surgery.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp and Dohme Corp
ClinicalTrials.gov Identifier: NCT00550732     History of Changes
Other Study ID Numbers: P05090
Study First Received: October 29, 2007
Last Updated: July 20, 2011
Health Authority: Canada: Health Canada

Keywords provided by Schering-Plough:
Triazoles

Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012



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