Clinical trial NCT00550732: A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
Official title: A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycoses
Keywords: Triazoles
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research Inc.
First posted: 2007-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment
timeFrame: Up to 6 months
Secondary outcomes:
measure: Number of Participants With ≥50% Decrease in Lesion Size or Number
timeFrame: Up to 6 months
measure: Percentage of Participants With a CR or PR by 12 Weeks
timeFrame: Up to 12 Weeks
measure: Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks
timeFrame: Up to 26 weeks
measure: Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug
timeFrame: Up to 6 months
measure: Overall Survival at 3 Months
timeFrame: 3 months
measure: Number of Participants With Response to Posaconazole in Combination Therapy
timeFrame: Up to 6 months
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
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