Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B deoxycholate with or without flucytosine followed by fluconazole for the treatment of cryptococcal meningitis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TTY Biopharm
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. Adults with age of at least 18 years.

2. Within 7 days prior to, or at the time of screening visit, patient with cryptococcus meningitis, diagnosed by :

1. CSF India ink staining positive OR

2. CSF cryptococcal antigen test positive OR

3. CSF culture positive

3. Patient or his/her legally acceptable representative has signed the written informed consent form.

Exclusion Criteria:

1. Patients have laboratory abnormalities within 3 days prior to screening visit :

1. ALT > 5x UNL,

2. AST > 5x UNL,

3. Creatinine > 2mg/dl

2. Patient is pregnant or lactating.

3. Patient participate other investigational drug trial within 1 month before entering this study.

4. Patient has some indications that another systemic antifungal drug would be needed in addition to assigned drugs in study.

5. Patient had contraindication of amphotericin B or azole.

6. Patient is not available for lumbar puncture.

7. Patient with life expectancy less than 5 days.