Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

H

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)

40 participants in 1 patient group

Intrathecal administration group
Experimental group
Treatment:
Drug: Liposomal amphotericin B

Trial contacts and locations

0

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Central trial contact

Hui Bu, MD

Data sourced from clinicaltrials.gov

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