UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059212 |
|---|---|
| Receipt number | R000067725 |
| Scientific Title | Evaluation of efficiency and safety for lascufloxacin drip infusion use for atypical pneumonia,including mycoplasma ,and legionella in the Saitama western area |
| Date of disclosure of the study information | 2025/10/02 |
| Last modified on | 2025/09/27 08:32:47 |
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Basic information
Public title
Evaluation of efficiency and safety for lascufloxacin drip infusion use for atypical pneumonia,including mycoplasma ,and legionella in the Saitama western area
Acronym
Evaluation of lascufloxacin drip infusion use for atypical pneumonia in the Saitama western area
Scientific Title
Evaluation of efficiency and safety for lascufloxacin drip infusion use for atypical pneumonia,including mycoplasma ,and legionella in the Saitama western area
Scientific Title:Acronym
Evaluation of lascufloxacin drip infusion use for atypical pneumonia in the Saitama western area
Region
| Japan |
Condition
Condition
atypical pneumonia,including mycoplasma ,and legionella
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficiency and safety for lascufloxacin drip infusion use for atypical pneumonia,including mycoplasma ,and legionella in the Saitama western area.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficiency at end of treatment
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) the adult
2) the cases those were diagnosed as atypical pneumonia and will be LSFX will be administered
3) the case those will be accepted the switch therapy: intravenous to oral
Key exclusion criteria
1) the cases those did not mycoplasma and legionella finally
2) the cases those have the contraindication for LSFX
3) the cases those have the too severe underlying diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Seki |
Organization
Saitama Medical University International Medical Center
Division name
Infectious diseases and infection control
Zip code
3501298
Address
Yamane 1397-1, Hidaka City, Saitama
TEL
+81-42-984-4392
sekimm@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Seki |
Organization
Saitama medical University International Medical center
Division name
infectious diseases and infection control
Zip code
3501298
Address
yamane 1397-1, Hidaka City, saitama
TEL
042-984-4392
Homepage URL
sekimm@saitama-med.ac.jp
Sponsor or person
Institute
saitama medical university
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
saitama medical university international medical center
Address
yamane 1397-1, hidaka city, saitama
Tel
+81-42-984-4392
sekimm@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
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
| 2025 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate the efficiency and safety for lascufloxacin drip infusion use for atypical pneumonia,including mycoplasma ,and legionella in the Saitama western area observationally.
Management information
Registered date
| 2025 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067725
