Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

Sponsor

Hui Bu (Other)

Overall Status

Unknown status

CT.gov ID

NCT02686853

Collaborator

(none)

Enrollment

Arm

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Cryptococcal Meningitis	Drug: Liposomal amphotericin B	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intrathecal administration group

Drug: Liposomal amphotericin B

Outcome Measures

Primary Outcome Measures

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

changes of clinical symptoms [2 to 4 weeks]
headache duration, duration of fever,presence of cranial nerve damage

Other Outcome Measures

The incidence of adverse reactions [24 hours]
Lower back pain，lower extremity weakness， paraplegia，sphincter disturbance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.