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
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
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
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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