UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against atypical pneumonia
Title of the study (Brief title)	Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against atypical pneumonia
Region	Japan

Condition
Condition	Atypical pneumonia
Classification by specialty	Medicine in general Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy and safety of Geninax(R) Tablets against atypical pneumonia in daily clinical practice To collect clinical data of patients with pneumonia caused by the following bacteria with which a sufficient number of patients infected could not be enrolled in the clinical studies of Geninax(R) Tablets (i.e., Mycoplasma pneumoniae and Chlamydophila pneumoniae)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Clinical efficacy at the termination of Geninax(R) Tablets therapy (assessed by primary physician) Adverse drug reaction during the observation period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Geninax(R) Tablets 200 mg was administered under the approved regimen (2 tablets of Geninax(R), once daily). The administration period was not limited.
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	Patients who were 15 years or older Patients who had a negative result on Streptococcus pneumoniae urinary antigen test Patients who were differentiated as having suspected atypical pneumonia according to the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults Patients who had infiltrative shadows that deemed to have appeared acutely and newly on chest radiographic images and not exceeded 2/3 of one lung Patients who had respiratory symptoms (e.g., cough, chest pain, or dyspnea) Patients who could ingest orally Patients who did not require a combination of other antibiotics or steroids when Geninax(R) Tablets therapy was initiated Patients who took no other antibiotics within 7 days before initiation of Geninax(R) Tablets therapy
Key exclusion criteria	Patients who had a history of hypersensitivity to Geninax(R) Tablets or other quinolones Patients who were pregnant or possibly pregnant or were lactating Patients who were previously enrolled in the study Patients in whom drug efficacy of Geninax(R) Tablets was difficult to assess Other patients whom the primary physician deemed to be ineligible as a target
Target sample size	100

Research contact person
Name of lead principal investigator	Shigeru Kohno
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Molecular Microbiology and Immunology
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki 852-8501, Japan
TEL	095-819-7273
Email	s-kohno@nagasaki-u.ac.jp

Public contact
Name of contact person	Satoru Kushimoto
Organization	Toyama Chemical Co., Ltd.
Division name	Post-Marketing Surveillance Group, Pharmacovigilance & Surveillance Department
Address	2-5, Nishishinjuku 3-chome, Shinjuku-ku, Tokyo 160-0023, Japan
TEL	03-5381-3877
Homepage URL
Email	satoru_kushimoto@toyama-chemical.co.jp

Sponsor
Institute	Toyama Chemical Co., Ltd.
Institute
Department

Funding Source
Organization	Toyama Chemical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 10 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 13 Day
Anticipated trial start date	2009 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.jiac-j.com/article/S1341-321X(14)00190-1/pdf
Results	The safety in 105 patients and the efficacy in 71 patients were examined. 1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients). The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain). 2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively.
Other related information	We did an interim presentation of this study at the 59th annual meeting of the Eastern Branch, Japanese Society of Chemotherapy.

Management information
Registered date	2013 Year 10 Month 25 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014149