A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: JSS Medical Research Inc.
• Treatments: Posaconazole

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.