Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

February 16, 2016 updated by: Hui Bu

Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Without Acquired Immune Deficiency Syndrome

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrathecal administration group
Drug: Liposomal amphotericin B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
laboratory examination of cerebrospinal fluid
Time Frame: 2 to 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of clinical symptoms
Time Frame: 2 to 4 weeks
headache duration, duration of fever,presence of cranial nerve damage
2 to 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse reactions
Time Frame: 24 hours
Lower back pain，lower extremity weakness， paraplegia，sphincter disturbance.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Bu

Investigators

  • Principal Investigator: Hui Bu, MD, The Second Hospital of Hebei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH 003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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