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 has been completed.

Sponsor:

Collaborator:

JSS Medical Research Inc.

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00550732

First received: October 29, 2007

Last updated: December 11, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 29, 2007
Last Updated Date	December 11, 2012
Start Date ^ICMJE	December 2007
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 11, 2012)	Proportion of participants with complete response (CR) or partial response (PR) [ Time Frame: At least 12 weeks or until end of treatment (up to 6 months) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 29, 2007)	Complete (resolution of clinical, radiologic and mycologic abnormalities, if present at baseline) or partial (meaningful improvement in clinical, radiologic and mycologic abnormalities, if present at baseline) response to posaconazole treatment. [ Time Frame: The proportion of subjects who respond to treatment will be reported at the end of treatment or at 12 weeks, whichever comes first. ]
Change History	Complete list of historical versions of study NCT00550732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 11, 2012)	Number of participants with ≥50% decrease in lesion size or number [ Time Frame: At least 12 weeks or until end of treatment (up to 6 months) ] [ 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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 29, 2007)	a) Response to treatment. b) Decrease in target lesion size. c) Time to response. d) Duration of clinical response. e) Infection-free survival at 6 months after the last study dose. f) Safety of posaconazole therapy. g) Survival at 3 months. [ Time Frame: 3 months to 6 months ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
Official Title ^ICMJE	A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study.
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Mycoses
Intervention ^ICMJE	Drug: posaconazole posaconazole oral suspension, 400 mg twice daily, or 200 mg 4 times daily for participants intolerant of food or nutritional supplements Other Names: SCH056592 Noxafil®
Study Arm (s)	Experimental: Posaconazole Intervention: Drug: posaconazole
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	November 2012
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00550732
Other Study ID Numbers ^ICMJE	P05090
Has Data Monitoring Committee	Yes
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	JSS Medical Research Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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