NCT02686853

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).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

January 26, 2016

Last Update Submit

February 16, 2016

Conditions

Cryptococcal Meningitis

Keywords

Intrathecal administrationLiposomal amphotericin BWithout Acquired Immune Deficiency Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    2 to 4 weeks

Secondary Outcomes (1)

  • changes of clinical symptoms

    2 to 4 weeks

Other Outcomes (1)

  • The incidence of adverse reactions

    24 hours

Study Arms (1)

Intrathecal administration group

EXPERIMENTAL
Drug: Liposomal amphotericin B

Interventions

Liposomal amphotericin BDRUG
Intrathecal administration group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cryptococcus neoformans are found in CSF

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningitis, Cryptococcal

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

Meningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesInfectionsCryptococcosisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Hui Bu, MD

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Bu, MD

CONTACT

86"buhuimy1@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 22, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Last Updated

February 22, 2016

Record last verified: 2016-02