Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

NCT ID: NCT02686853

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Cryptococcal Meningitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intrathecal administration group

Group Type EXPERIMENTAL

Liposomal amphotericin B

Intervention Type DRUG

Interventions

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Liposomal amphotericin B

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hui Bu

OTHER

Sponsor Role lead

Responsible Party

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Hui Bu

Study Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hui Bu, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Central Contacts

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Hui Bu, MD

Role: CONTACT

Other Identifiers

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BH 003

Identifier Type: -

Identifier Source: org_study_id

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