Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

Cryptococcal Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02686853
• Other study ID #: BH 003
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 26, 2016
• Last updated: February 16, 2016
• Start date: January 2016

Study information

• Verified date: February 2016
• Source: Hebei Medical University
• Contact: Hui Bu, MD
• Phone: 86"
• Email: buhuimy1[@]163.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cryptococcal Meningitis
• HIV Infections
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Liposomal amphotericin B

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hui Bu

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of adverse reactions	Lower back pain,lower extremity weakness, paraplegia,sphincter disturbance.	24 hours	Yes
Primary	laboratory examination of cerebrospinal fluid	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	No
Secondary	changes of clinical symptoms	headache duration, duration of fever,presence of cranial nerve damage	2 to 4 weeks	No