Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063347) titled 'Optimization of the Duration of Liposomal Amphotericin B Induction Therapy in HIV-Negative Cryptococcal Meningitis or Disseminated Cryptococcosis' on Oct. 19.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Cryptococcal meningitis or disseminated cryptococcosis in HIV-negative patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To estimate the difference in 30-day same-institution recorded mortality risk between standard-duration strategy B and prolonged strategy C among HIV-negative adults newly initiating liposomal amphotericin B (L-AmB) for cryptococcal meningitis or disseminated cryptococcosis in the JMDC Medical Institution Database. Strategy B requires daily L-AmB on days 1-8, usual care on days 9-14, and prespecified day-15/day-16 initial-course termination rules. Strategy C requires daily L-AmB on days 1-15, followed by usual care. A target trial will be emulated using clone-censor-weighting, with first L-AmB administration as time zero. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age 18 years or older at first liposomal amphotericin B (L-AmB) administration (time zero). 2. Cryptococcal meningitis (ICD-10 B45.1) or disseminated cryptococcosis (B45.7) recorded as a non-suspected main diagnosis or admission-precipitating diagnosis during the index DPC hospitalization. 3. Initiation of L-AmB during the index hospitalization. 4. The first observed eligible episode within the fixed extraction period of the JMDC Medical Institution Database (April 2014-August 2025). Key exclusion criteria - 1. A non-suspected HIV diagnosis (ICD-10 B20-B24 or Z21) recorded through index discharge, using the diagnosis-record windows and date-handling rules specified in SAP Section 7.2. 2. Transfer-in admission from another hospital (DPC Form 1 admission route 4). 3. Any recorded amphotericin B exposure before time zero at the same institution, regardless of formulation and including records before the index admission. 4. A previous hospitalization for B45.1 or B45.7 with amphotericin treatment in the available same-institution lookback. 5. Courses treated exclusively with amphotericin B deoxycholate without L-AmB. Target Size - 115

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 20 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 10 Month 21 Day Last follow-up date - 2026 Year 10 Month 21 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072493

Disclaimer: Curated by HT Syndication.