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Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)

Primary Purpose

Fungal Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Posaconazole
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Infection focused on measuring refractory or first line medication intolerable invasive fungal infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must be 18-70 years male or female
  • Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment.
  • Sign informed consent form

Exclusion Criteria:

  • Female participants who are pregnant or are nursing.
  • Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B
  • Participants with progressive nervous system diseases( excluding those IFI caused)

  • Participants who take the following drugs known with interference with azole antifungal preparations

    • terfenadine, cisapride, and ebastine within 24 hours before entry
    • astemizole at entry or within 10 days before entry
    • cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
  • The drugs listed above are prohibited during the investigation
  • Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
  • Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
  • Expected to take during investigation or is taking systemic antifungal treatment
  • Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are >2×ULN.
  • Participants expected to survive no more than 72hrs
  • Participants receiving artificial aeration and will not withdraw within 24hrs
  • Participants who have used any investigational drugs or biologic agents or anticipated other clinical trials within 30 days of study entry.
  • Prior enrollment in this study.
  • History of alcohol and/or drug abuse.
  • Participants cannot be compliant in investigator's opinion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Posaconazole

    Arm Description

    Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks

    Outcomes

    Primary Outcome Measures

    Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
    EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.

    Secondary Outcome Measures

    Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment
    EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.
    Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment
    EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.
    Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment
    EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
    Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment
    EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
    Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment
    EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
    Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up
    Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.

    Full Information

    First Posted
    December 18, 2008
    Last Updated
    March 9, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00811642
    Brief Title
    Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
    Official Title
    A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fungal Infection
    Keywords
    refractory or first line medication intolerable invasive fungal infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Posaconazole
    Arm Type
    Experimental
    Arm Description
    Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Posaconazole
    Other Intervention Name(s)
    Noxafil
    Intervention Description
    400mg BID oral suspension for 12 weeks
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
    Description
    EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.
    Time Frame
    Treatment week 12
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment
    Description
    EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.
    Time Frame
    Treatment week 4
    Title
    Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment
    Description
    EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.
    Time Frame
    Treatment week 8
    Title
    Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment
    Description
    EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
    Time Frame
    Treatment week 4
    Title
    Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment
    Description
    EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
    Time Frame
    Treatment week 8
    Title
    Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment
    Description
    EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
    Time Frame
    Treatment week 12
    Title
    Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up
    Description
    Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.
    Time Frame
    Follow-up week 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must be 18-70 years male or female Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment. Sign informed consent form Exclusion Criteria: Female participants who are pregnant or are nursing. Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B Participants with progressive nervous system diseases( excluding those IFI caused) Participants who take the following drugs known with interference with azole antifungal preparations terfenadine, cisapride, and ebastine within 24 hours before entry astemizole at entry or within 10 days before entry cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry The drugs listed above are prohibited during the investigation Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities. Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women. Expected to take during investigation or is taking systemic antifungal treatment Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are >2×ULN. Participants expected to survive no more than 72hrs Participants receiving artificial aeration and will not withdraw within 24hrs Participants who have used any investigational drugs or biologic agents or anticipated other clinical trials within 30 days of study entry. Prior enrollment in this study. History of alcohol and/or drug abuse. Participants cannot be compliant in investigator's opinion.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    22324990
    Citation
    Huang X, Wang F, Chen Y, Liu T, Wang J, Hu J, Jie J, Chen F, Wang S, Shen Z, Yu L, Yu K, Liang Y. A multicenter, open-label study of posaconazole oral suspension in the treatment of invasive fungal infections in patients refractory to or intolerant of first-line therapy. Future Microbiol. 2012 Feb;7(2):201-9. doi: 10.2217/fmb.11.158.
    Results Reference
    result

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    Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)

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