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Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

Primary Purpose

Cryptococcal Meningitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Liposomal amphotericin B
Sponsored by
Hui Bu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryptococcal Meningitis focused on measuring Intrathecal administration, Liposomal amphotericin B, Without Acquired Immune Deficiency Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Cryptococcus neoformans are found in CSF

Exclusion Criteria:

  • Patients with serious heart, lung, liver and renal insufficiency.
  • Patients who took broad-spectrum antibiotics and corticosteroids for a long-term.
  • Patients with AIDS or obvious immunodeficiency.
  • Patients with long term dialysis or intravenous catheter.
  • Patients with other brain organic disease such as purulent meningitis, intracranial swelling, etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intrathecal administration group

    Arm Description

    Outcomes

    Primary Outcome Measures

    laboratory examination of cerebrospinal fluid
    It includes routine test，biochemistry indicators and cytology ，namely white blood cell count per litre， protein（in g/l），glucose（in mmol/l）and chloride（in mmol/l）in cerebrospinal fluid ，an assessment will be assessed every week

    Secondary Outcome Measures

    changes of clinical symptoms
    headache duration, duration of fever,presence of cranial nerve damage

    Full Information

    First Posted
    January 26, 2016
    Last Updated
    February 16, 2016
    Sponsor
    Hui Bu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02686853
    Brief Title
    Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis
    Official Title
    Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Without Acquired Immune Deficiency Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hui Bu

    4. Oversight

    5. Study Description

    Brief Summary
    The main purpose of this study is to observe the clinical effect of intrathecal administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune Deficiency Syndrome (AIDS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cryptococcal Meningitis
    Keywords
    Intrathecal administration, Liposomal amphotericin B, Without Acquired Immune Deficiency Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intrathecal administration group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Liposomal amphotericin B
    Primary Outcome Measure Information:
    Title
    laboratory examination of cerebrospinal fluid
    Description
    It includes routine test，biochemistry indicators and cytology ，namely white blood cell count per litre， protein（in g/l），glucose（in mmol/l）and chloride（in mmol/l）in cerebrospinal fluid ，an assessment will be assessed every week
    Time Frame
    2 to 4 weeks
    Secondary Outcome Measure Information:
    Title
    changes of clinical symptoms
    Description
    headache duration, duration of fever,presence of cranial nerve damage
    Time Frame
    2 to 4 weeks
    Other Pre-specified Outcome Measures:
    Title
    The incidence of adverse reactions
    Description
    Lower back pain，lower extremity weakness， paraplegia，sphincter disturbance.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cryptococcus neoformans are found in CSF Exclusion Criteria: Patients with serious heart, lung, liver and renal insufficiency. Patients who took broad-spectrum antibiotics and corticosteroids for a long-term. Patients with AIDS or obvious immunodeficiency. Patients with long term dialysis or intravenous catheter. Patients with other brain organic disease such as purulent meningitis, intracranial swelling, etc.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hui Bu, MD
    Phone
    86"
    Email
    buhuimy1@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hui Bu, MD
    Organizational Affiliation
    The Second Hospital of Hebei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

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