UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063347 |
|---|---|
| Receipt number | R000072493 |
| Scientific Title | Comparative Effectiveness of Standard-Duration (8-14 Days) Versus Prolonged (15 Days or More) Liposomal Amphotericin B Induction in HIV-Negative Cryptococcal Meningitis or Disseminated Cryptococcosis: A Target Trial Emulation Using the JMDC Medical Institution Database |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/19 19:13:29 |
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Basic information
Public title
Optimization of the Duration of Liposomal Amphotericin B Induction Therapy in HIV-Negative Cryptococcal Meningitis or Disseminated Cryptococcosis
Acronym
Crypto-AmB TTE
Scientific Title
Comparative Effectiveness of Standard-Duration (8-14 Days) Versus Prolonged (15 Days or More) Liposomal Amphotericin B Induction in HIV-Negative Cryptococcal Meningitis or Disseminated Cryptococcosis: A Target Trial Emulation Using the JMDC Medical Institution Database
Scientific Title:Acronym
Crypto-AmB TTE
Region
| Japan |
Condition
Condition
Cryptococcal meningitis or disseminated cryptococcosis in HIV-negative patients
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Death recorded at the data-providing institution through day 30, with first L-AmB administration defined as day 1 (from t0 through t0+29 days). This includes deaths during the index hospitalization or readmission to the same institution. The primary effect measure is the 30-day mortality risk difference between prolonged strategy C and standard-duration strategy B (C minus B).
Key secondary outcomes
Death recorded at the data-providing institution through day 70, with first L-AmB administration defined as day 1 (from t0 through t0+69 days). This includes deaths during the index hospitalization or readmission to the same institution. Mortality risk differences and risk ratios comparing prolonged strategy C with standard-duration strategy B will be estimated.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | Minoda |
| Last name | Sada |
Organization
Graduate School of Medicine, The University of Osaka
Division name
Department of Transformative Analysis for Human Specimen,
Zip code
565-0871
Address
1-10 Yamadaoka, Suita, Osaka, Japan
TEL
+81-6-6105-6259
sadao@cider.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | Minoda |
| Last name | Sada |
Organization
Graduate School of Medicine, The University of Osaka
Division name
Department of Transformative Analysis for Human Specimen
Zip code
565-0871
Address
1-10 Yamadaoka, Suita, Osaka, Japan
TEL
+81-6-6105-6259
Homepage URL
sadao@cider.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Ryuichi Minoda Sada
Funding Source
Organization
none.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Observational Studies, The University of Osaka Hospital
Address
rinri@hp-crc.med.osaka-u.ac.jp
Tel
06-6210-8296
sadao@cider.osaka-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
10.17605/OSF.IO/D6YE8
Org. issuing International ID_1
Open Science Framework (OSF)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学大学院医学系研究科変革的ヒト検体解析学（日本財団）寄附講座（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 19 | Day |
Related information
URL releasing protocol
https://doi.org/10.17605/OSF.IO/D6YE8
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under evaluation
Management information
Registered date
| 2026 | Year | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072493
