Clinical Trial: Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Open Label Parallel Controlled, Multicenter Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension Vs. Fluconazole (Capsule) in High-risk Leukopenic Patients for Preventio

Brief Summary: A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period [ Time Frame: Up to 12 Weeks (84 days) plus 7 days ]

Number of participants developing a proven or probable IFI from randomization to the last dosage date (up to 12 weeks [84 days]) plus 7 days. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.


Original Primary Outcome: Incidence of proven or clinical IFI during treatment [ Time Frame: Randomization date to last dosage date plus 7days ]

Current Secondary Outcome:

  • Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization [ Time Frame: From randomization date to Day 100 ]
    Number of participants who developed a proven or probable IFI from randomization date to Day 100 of follow-up visit. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.
  • Time From Randomization to the First Onset of Proven or Probable IFI [ Time Frame: From randomization date to Day 100 ]
    The time measured in days to the first occurrence of proven/probable IFI diagnosis in the entire FAS population from randomization to Day 100 of follow-up visit. Participants may not have accepted immediate antifungal treatment and later received antifungal treatment based upon further investigator review of the participant's IFI condition. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, positive blood/biopsy cultures with corresponding clinical signs and symptoms.
  • Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy [ Time Frame: Up to 12 weeks (84 days) ]
    The time measured in days from randomization to the administration of the first concomitant systemic anti-fungal therapy in the entire FAS population. Not all participants who accepted systemic anti-fungal therapy may have had a IFI clinical diagnosis. IFI diagnosis criteria for antifungal therapy administration may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.
  • Number of Participants With Clinical Failure During Treatment [ Time Frame: Up to 12 weeks (84 days) ]

    Clinical failure was defined as follows:

    • Presence of a proven or probable IFI
    • Systemic antifungal treatment (IV) for 4 consecutive days or more than 10 days total
    • Discontinuation due to adverse event (AE) possibly or probably related to study drug
    • Lost-to-follow-up or discontinuation from the study for any reason with loss to follow-up during the Treatment Phase
  • Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization [ Time Frame: Randomization date to Day 100 ]
    Death from any cause.
  • Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization [ Time Frame: From randomization date to Day 100 ]

    Exact Causes of Death and Their Relationship to IFI Episode Were As Follows:

    • Unlikely related: participant completed treatment and cause of death was due to primary disease or complication
    • Possibly related: IFI undergoing treatment without stabilization, or with failure to have a complete remission, where cause of death might have been due to IFI, including progression or relapse of primary disease
    • Probably related: autopsy or clinical signs suggested that progression of IFI was the probable cause of death


Original Secondary Outcome:

  • Incidence of proven or clinical IFI from randomization date to Day 100 [ Time Frame: From randomization date to Day 100 ]
  • The first occurrence of proven or clinical IFI from randomization [ Time Frame: From randomization date to Day 100 ]
  • The first application of systematic anti-fungal treatment from randomization [ Time Frame: From randomization date to Day 100 ]
  • Clinical failure rate during treatment [ Time Frame: From randomization date to Day 100 ]
  • All-cause mortality rate in 100 days [ Time Frame: From randomization date to Day 100 ]
  • Mortality rate related to fungal infection in 100 days [ Time Frame: From randomization date to Day 100 ]


Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: December 18, 2008
Date Started: November 2008
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017