Clinical Trial: POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)

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

Official Title: A Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy, Two-Arm Study of Posaconazole vs Fluconazole in the Treatment of Coccidioidomycosis

Brief Summary: To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants received posaconazole for a treatment duration not to exceed 12 months.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

• Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A [ Time Frame: 12 months ]

  Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.

  Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication.

• Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B [ Time Frame: 12 months ]

  Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.

  Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication.

Original Primary Outcome:

Current Secondary Outcome:

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A [ Time Frame: 12 months ]
  Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.
• Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B [ Time Frame: 12 months ]
  Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.
• Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A [ Time Frame: 12 months ]
  Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.
• Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B [ Time Frame: 12 months ]
  Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.
• Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A [ Time Frame: 12 months ]
• Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B [ Time Frame: 12 months ]

Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: January 17, 2007
Date Started: May 2007
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017