UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049139 |
|---|---|
| Receipt number | R000055976 |
| Scientific Title | Evaluation of the safety and efficacy of lascufloxacin for Legionella pneumonia |
| Date of disclosure of the study information | 2022/10/06 |
| Last modified on | 2022/10/06 13:12:54 |
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Basic information
Public title
Evaluation of the safety and efficacy of lascufloxacin for Legionella pneumonia
Acronym
Safety and efficacy of lascufloxacin for Legionella
Scientific Title
Evaluation of the safety and efficacy of lascufloxacin for Legionella pneumonia
Scientific Title:Acronym
Safety and efficacy of lascufloxacin for Legionella
Region
| Japan |
Condition
Condition
Legionella pneumonia
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of lascufloxacin for Legionella pneumonia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. 30-day mortality
2. In-hospital mortality
Key secondary outcomes
1. Duration of admission
2. Pneumonia recurrence requiring antibiotic therapy
3. Time to defervescence from start of lascufloxacin (Defervescence was defined in days after the first 24 hours from less than 37.8 degree Celsius or less than 37.0 degree Celsius)
4. Intensive care unit admission, ventilatory support and vasopressor use due to exacerbation of pneumonia
5. Adverse drug effects
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients, aged 15 years or more, diagnosed with Legionella pneumonia.
Community-onset pneumonia patients.
Patients who consent to participation in the study (consent by proxy is permitted).
Key exclusion criteria
Patients treated with antibiotics other than lascufloxacin.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Ito |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
ai12306@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Ito |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
ai12306@kchnet.or.jp
Sponsor or person
Institute
Ohara Healthcare Foundation, Kurashiki Central Hospital, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital Ethics Committee
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
086-422-0210
ai12306@kchnet.or.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
| 2022 | Year | 10 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is designed as a prospective observational study.
All hospitalized patients with Legionella pneumonia treated using lascufloxacin will be enrolled.
In all patients, the following clinical data will be investigated:
age, sex, smoking habit, comorbidities, history of visiting a hot spring or spa, history of soil exposure, symptoms, oral medicines, vital signs, blood tests, microbiological tests, chest radiological examinations, severity of pneumonia (A-DROP, CURB-65, Pneumonia Severity Index), treatment, and prognosis.
To evaluate the safety and efficacy of lascufloxacin, we plan to compare the study subjects with Legionella pneumonia patients treated using levofloxacin as a historical control.
Management information
Registered date
| 2022 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055976
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
