Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Not Applicable

• Conditions: Cryptococcal Meningitis
• Interventions: Drug: Amphotericin B-deoxycholate; Drug: Liposomal amphotericin B

• Registration Number: NCT02136030
• Lead Sponsor: TTY Biopharm

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2011-02
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Last Update Submitted: 2014-05-08
• Study First Posted: 2014-05-12
• Last Update Posted: 2014-05-12
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amphotericin B	Amphotericin B-deoxycholate	-
Lipo-AB	Liposomal amphotericin B	-

Primary Outcome Measures

Name	Time	Method
suscceful response rate	Day 14	Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan