A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections(Study P05090) - Full Text View

Sponsors and Collaborators:	Schering-Plough 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 subjects with fungal infections who are refractory to one prior line of antifungal therapy.

Condition	Intervention	Phase
Mycoses	Drug: SCH56592	Phase II

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Posaconazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Posaconazole for the Early Treatment of Refractory Fungal Infections. The "EARLY-POS" Study.

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	33
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Posaconazole: Experimental Subjects will receive 400 mg of posaconazole twice daily for 12 weeks, or up to 6 months	Drug: SCH56592 400 mg twice daily for 12 weeks, or up to 6 months

Detailed Description:

In the past two decades, invasive fungal infections have become increasingly common among immunocompromised subjects, including solid-organ or hematopoietic stem-cell transplant recipients, subjects with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with invasive fungal infections. 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. This is a non randomized, prospective, multi-centre, Phase II study to evaluate the efficacy and safety of posaconazole when used early in the treatment of refractory fungal infections.

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:
- Proven is defined as: microbiologic or histologic evidence of fungi in normally sterile tissues/fluids.
- Probable is defined as: signs and symptoms consistent with infection; at least 1 criterion from microbiologic, host, and clinical sections.
Refractory or intolerant to ONE prior antifungal therapy:
- Refractory is defined as: disease progression or failure to respond or improve clinically despite antifungal therapy. Failure is defined as a minimum of 7 days of therapy to one standard antifungal drug.
- Intolerant is defined as: subjects who are treated with a standard antifungal drug for less than 7 days but who experience intolerance or toxicities that are clinically unacceptable.
- Subjects who have switched from standard to liposomal formulation of Amphotericin B due to toxicity.
At risk for/or demonstrated organ toxicity (eg, renal failure) precluding standard antifungal treatment or who have not been previously treated with a standard antifungal drug may be included in the study if they have a documented prior history of serious, severe or life-threatening illness or a medical condition (eg, renal impairment) that precludes the use of standard antifungal therapy. These subjects will require sponsor approval before being enrolled into the study.
Age >= 13 years old. For adolescents aged 13-17 years old, a parent or legal guardian must provide written informed consent.
Expected to survive >1 month.
Signed informed consent form.
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 AST or ALT >10 times ULN.
Documented allergy to azoles.
Unable to take oral suspension medications or enteral feeding.
Pregnant or breastfeeding.
Does not wish to undergo therapy.
Not a suitable candidate for posaconazole therapy according to the investigator's medical judgment.
Patients on dialysis are allowed to enroll in the study.
Patients who have received an investigational drug are allowed to be enrolled if the investigational drug was given 30 days prior to Subject Registration.
Requires surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550732

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Canada
Investigational Site 2	Recruiting
Montreal, Canada, H1T2M4
Investigational Site 1	Recruiting
Edmonton, Canada, T6G 2B7
Investigational Site 6	Recruiting
Winnipeg, Canada, R3A 1R9
Investigational Site 7	Recruiting
Montreal, Canada, H3T 1C5
Investigational Site 4	Recruiting
Vancouver, Canada, V6Z 1Y6
Investigational Site 3	Recruiting
Hamilton, Canada, L8V 1C3

Sponsors and Collaborators

Schering-Plough

JSS Medical Research Inc.

Investigators

Study Chair:

Michel Laverdière, M.D.

Hôpital Maisonneuve-Rosemont

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05090, SCH 056592
Study First Received:	October 29, 2007
Last Updated:	December 14, 2008
ClinicalTrials.gov Identifier:	NCT00550732
Health Authority:	Canada: Therapeutic Products Directorate

Keywords provided by Schering-Plough:

Triazoles
Mycoses

Study placed in the following topic categories:

Mycoses
Clotrimazole
Miconazole
Tioconazole
Posaconazole

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents

Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009