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A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105) (PAPAL)

Primary Purpose

Fungal Infection

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Posaconazole
Calogen®
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fungal Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Scheduled to undergo lung transplantation
  • Able to take oral/nasogastric medication
  • Females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study.

Exclusion Criteria:

  • Severe liver disease
  • Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant
  • Treatment with posaconazole within 14 days before transplant
  • Breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Posaconazole - CF Participants

    Posaconazole - Non-CF Participants

    Arm Description

    Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.

    Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.

    Outcomes

    Primary Outcome Measures

    Time to Reach 90% of the Steady State Serum Concentration of Posaconazole
    Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.
    Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum
    Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.

    Secondary Outcome Measures

    Percentage of Participants Who Develop Invasive Fungal Infection
    Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.

    Full Information

    First Posted
    August 14, 2012
    Last Updated
    September 10, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01667107
    Brief Title
    A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
    Acronym
    PAPAL
    Official Title
    A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study terminated due to an unfavorable risk-benefit analysis
    Study Start Date
    January 23, 2013 (Actual)
    Primary Completion Date
    January 16, 2014 (Actual)
    Study Completion Date
    January 16, 2014 (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
    This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fungal Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Posaconazole - CF Participants
    Arm Type
    Experimental
    Arm Description
    Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
    Arm Title
    Posaconazole - Non-CF Participants
    Arm Type
    Experimental
    Arm Description
    Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
    Intervention Type
    Drug
    Intervention Name(s)
    Posaconazole
    Other Intervention Name(s)
    SCH056592, MK-5592, Noxafil®
    Intervention Type
    Drug
    Intervention Name(s)
    Calogen®
    Primary Outcome Measure Information:
    Title
    Time to Reach 90% of the Steady State Serum Concentration of Posaconazole
    Description
    Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.
    Time Frame
    Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
    Title
    Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum
    Description
    Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.
    Time Frame
    Up to Day 42
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Who Develop Invasive Fungal Infection
    Description
    Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.
    Time Frame
    Up to Day 84

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Scheduled to undergo lung transplantation Able to take oral/nasogastric medication Females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study. Exclusion Criteria: Severe liver disease Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant Treatment with posaconazole within 14 days before transplant Breastfeeding
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=5592-105&kw=5592-105&tab=access

    Learn more about this trial

    A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)

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