A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (Study P05090)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses
Intervention: SCH 056592 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Summary
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.
Clinical Details
Official title: A Phase II Study of Posaconazole for the Early Treatment of Refractory Fungal Infections. The "EARLY-POS" Study.
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 1, Edmonton T6G 2B7, Canada; Recruiting
Investigational Site 3, Hamilton L8V 1C3, Canada; Recruiting
Investigational Site 2, Montreal H1T2M4, Canada; Recruiting
Investigational Site 7, Montreal H3T 1C5, Canada; Recruiting
Investigational Site 5, Toronto M5G 2M9, Canada; Recruiting
Investigational Site 4, Vancouver V6Z 1Y6, Canada; Recruiting
Investigational Site 6, Winnipeg R3A 1R9, Canada; Recruiting
Additional Information
Starting date: December 2007
Ending date: October 2011
Last updated: September 14, 2009
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