Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

TTY Biopharm

Status: Unknown

Conditions: Cryptococcal Meningitis

Treatments: Drug: Amphotericin B-deoxycholate; Drug: Liposomal amphotericin B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02136030

TTYLA0701

Details and patient eligibility

About

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.

Full description

Subjects who meet all eligible requirements will be randomized into study group （Lipo-AB）or control group（Amphotericin B deoxycholate） in 2:1 ratio. Subjects will be treated with induction therapy in study group or in control group with flucytosine for at least 14 days, and followed by consolidation therapy for another 56 days after CSF sterilization.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Lipo-AB

Experimental group

Treatment:

Drug: Liposomal amphotericin B

Amphotericin B

Active Comparator group

Treatment:

Drug: Amphotericin B-deoxycholate