NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061200015

Registered date:28/09/2020

Lascufloxacin hydrochloride clinical study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPneumonia
Date of first enrollment02/11/2020
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Lascufloxacin hydrochloride administration

Outcome(s)

Primary Outcome1) Changes in intestinal bacterial flora in healthy volunteer and pneumonia patient
Secondary Outcome1) C. difficile detection and C. difficile toxin expression in healthy volunteer 2) Comparison of intestinal microflora between healthy volunteer and pneumonia patient 3) Changes in oral flora in healthy volunteer and pneumonia patient 4) Comparison of oral flora between healthy volunteer and pneumonia patient 5) Relationship between intestinal bacterial flor and oral flora in healthy volunteer and pneumonia patient, individually 6) Relationshio between serum chemistry and intestinal bacterial flor or oral flora 7) Safery

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaHealthy male volunteer 1) 20-45 years old healthy Japanese male 2) BMI of 18.5-25.0 3) Subject who was judged healthy by investigator at screening and hospital admission visit 4) Subject who do not have a tendency to constipate and have a habit of daily bowel movements 5) Subject who can defecate before administration of study drug Pneumonia patient 1) 20 or above years old Japanese 2) Patients who were determined to administer Lascufloxacin hydrochloride by investigator 3) Patient with a clear infiltrative shadow on the chest X-ray or CT image taken within 48 hours before the start of study drug administration 4) Patient with symptoms suspected of respiratory infection 5) Patient who do not have a tendency to constipate and have a habit of daily bowel movements 6) Patient who can defecate before administration of study drug
Exclude criteriaHealthy male volunteer 1) Subject with a history of hypersensitivity or serious adverse effects to quinolone antibiotics 2) Subject who have unsuitable medical history as a study subject or a history of abdominal surgery that may affect drug absorption 3) Subject who have drunk excessively or cannot keep drinking during the study period 4) Subject who received antibacterial drugs within 28 days before study drug administration or who schedule to administer antibacterial drugs during the study period 5) Subject who received lactic acid bacteria beverage within 7 days before study drug administration 6) Subject who have a positive immunoserologic test at the screening test 7) Subject who have participated in other clinical trials or clinical researches of unapproved drugs within 3 months before registration Pneumonia patient 1) Patient with a history of hypersensitivity or serious adverse effects to quinolone antibiotics 2) Patient who are pregnant or nursing or who desire to become pregnant during the study period. Patient who is unwilling to agree to practice appropriate contraception during the study period 3) Lactating female patient 4) Patinet who have unsuitable medical history as a study subject or a history of abdominal surgery that may affect drug absorption 5) Patient who have drunk excessively or cannot keep drinking during the study period 6) Patient who received antibacterial drugs within 28 days before study drug administration or who schedule to administer antibacterial drugs during the study period 7) Subject who received lactic acid bacteria beverage within 7 days before study drug administration 8) Subject who have participated in other clinical trials or clinical researches of unapproved drugs within 3 months before registration

Related Information

Contact

Public contact
Name Yusuke Endo
Address 36-1 Nishi-cho, Yonago, Tottori Japan Tottori Japan 683-8504
Telephone +81-859-38-6946
E-mail y-endo@tottori-u.ac.jp
Affiliation Tottori University Hospital
Scientific contact
Name Hiroki Chikumi
Address 36-1 Nishi-cho, Yonago, Tottori Japan Tottori Japan 683-8504
Telephone +81-859-38-6078
E-mail chikumi@tottori-u.ac.jp
Affiliation Tottori University Hospital