Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

Phase 4

• Conditions: Cryptococcal Meningitis
• Interventions: Drug: Liposomal amphotericin B

• Registration Number: NCT02686853
• Lead Sponsor: Hui Bu

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-26
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrathecal administration group	Liposomal amphotericin B	-

Primary Outcome Measures

Name	Time	Method
laboratory examination of cerebrospinal fluid	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

Secondary Outcome Measures

Name	Time	Method
changes of clinical symptoms	2 to 4 weeks	headache duration, duration of fever,presence of cranial nerve damage