Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

Hui Bu

Status and phase: Unknown; Phase 4

Conditions: Cryptococcal Meningitis

Treatments: Drug: Liposomal amphotericin B

Study type: Interventional

Funder types: Other

Identifiers

NCT02686853

BH 003

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intrathecal administration group

Experimental group

Treatment:

Drug: Liposomal amphotericin B