UMIN-CTR Clinical Trial

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
Email	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
Email	ai12306@kchnet.or.jp

Sponsor
Institute	Ohara Healthcare Foundation, Kurashiki Central Hospital, Department of Respiratory Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055976