UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy of garenoxacin for treatment of bacterial respiratory infection secondary to chronic respiratory disease
Title of the study (Brief title)	GARIREO study
Region	Japan

Condition
Condition	Bacterial respiratory infection secondary to chronic respiratory disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) To evaluate the efficacy of garenoxacin for bacterial respiratory infection secondary to chronic respiratory disease 2) To evaluate the effects of garenoxacin on clinical symptoms in the early stage of treatment For the above objectives 1 and 2, the efficacy is also to be examined in subgroups of elderly patients with COPD and/or asthma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall improvement in the clinical efficacy will be evaluated as effective, not effective or unevaluable at the end of treatment (at 7 days of treatment +-2 days). [Efficacy evaluation criteria] Reference should be made to the Efficacy evaluation criteria at the end of treatment (below) defined in Clinical Evaluation Methods for New Antimicrobial Agents to Treat Respiratory Infections (2nd version) 1. Effective: when the following a and b are fulfilled. a. Disappearance or improvement of symptoms and signs. -Improvement in symptoms and signs (e.g. cough, sputum [amount/nature], fever, dyspnea, and general malaise) will be evaluated based on changes from baseline. -Improvement of cough or sputum is mandatory. - When symptoms and signs other than cough and sputum were observed at baseline, 1 or more symptom(s)/sign(s) should be improved. - For patients who have fever at baseline, improvement of fever is mandatory. -When the fever decreased from the baseline level, it should be deemed improved even if the body temperature is still >=37degrees Celsius. b. Disappearance or improvement of inflammatory signs -Either one of the following is fulfilled: Decrease in white blood cell count to <=8,000 mm3 or decrease in CRP from the peak level. In addition, there should be no parameters worsened. Of note, an increase in white blood cell count within the institutional normal range should not be regarded as worsened. 2. Not effective: When the above conditions (1. Effective) are not fulfilled. 3. Unevaluable: Either one of the following criteria is met. a. Information to determine symptoms and signs are insufficient (e.g. patients did not visit to hospital at the end of treatment). b. There are other definitive reasons for worsening of body temperature, white blood cell count and CRP.
Key secondary outcomes	Changes in the following parameters from baseline will be evaluated (including patients aged >=65 years). 1. Improvement in the laboratory parameters and imaging findings (blood test, imaging, bacteriological examination, etc.) at the end of treatment (at 7 days of treatment +-2 days) 2. After the follow-up period (at 7 days after the end of treatment +-2 days). -Test of cure Patients will be evaluated as cured, not cured, or unevaluable. (1) Cured: At the end of treatment, symptoms/signs have disappeared or improved without subsequent relapse or recurrence and need for alternative antimicrobial treatment. (2) Not cured: Symptoms/signs are unchanged or worsened and alternative antimicrobial treatment is required. 3. Improvement / changes in clinical symptoms and fever recorded in patient's diary (during the treatment period). 4. The early-phase treatment response observed at 3 days after treatment (as recorded in patient's diary). Patients will be evaluated as with early-phase treatment response,with no early-phase treatment response,or unevaluable (for the criteria, see the Efficacy evaluation criteria stated in the primary outcome section. With early-phase treatment response: Marked improvement is observed at 3 days after treatment (irrelevant whether the treatment is discontinued or continued after 4 days onwards).

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	Treatment with garenoxacin
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who fulfill the following criteria will be included. 1) Patients (both sexes) who visited our hospital, and were aged >=20 years at the time of giving informed consent 2) Patients who have cough or one of the following symptoms: worsening of dyspnea, increased purulent sputum or worsening of purulent sputum, and are suspected bacterial infection 3) Patients with fever of >=37degrees Celsius (axillary temperature) 4) Patients who have given written informed consent to participate in the study 5) patients presenting a new infiltrative shadow (in case of pneumonia)
Key exclusion criteria	Patients who meet any one of the following criteria will be excluded. 1) Patients with severe infection, for which ambulatory treatment with oral antibacterial drugs is not suitable 2) Patients with infection caused by pathogens for which garenoxacin is considered ineffective 3) Patients whose symptoms improve within 7 days before the start of treatment with garenoxacin 4) Patients who are being treated with other systemic antibacterial drugs (patients being treated with a small-dose long-term treatment with macrolide antibiotics without dosage change are acceptable for registration). 5) Patients who are hypersensitive to or have a history of hypersensitivity to or serious adverse events by quinolone antibacterial drugs. 6) Pregnant or possibly pregnant patients 7) Patients with low body weight (<40 kg) 8) Patients with severe renal function disorder (Ccr <30mL/min) or hepatic function disorder 9) Patients who have received systemic treatment with corticosteroids (prednisolone equivalent dose >10mg/day) (patients who have been treated with inhaled steroids without dosage change are acceptable for registration). 10) Patients who have been registered already. 11) Patients who are deemed inappropriate to participate in the study by investigators/subinvestigators for other reasons.
Target sample size	120

Research contact person
Name of lead principal investigator	Hironori Sagara
Organization	Showa University School of Medicine
Division name	Department of Medicine, Division of Allergology and Respiratory Medicine
Address	1-5-8 Hatanodai Shinagawa-ku, Tokyo
TEL	03-3784-8704
Email	kokyuuki@med.showa-u.ac.jp

Public contact
Name of contact person	Akihiko Tanaka
Organization	Showa University School of Medicine
Division name	Department of Medicine, Division of Allergology and Respiratory Medicine
Address	1-5-8 Hatanodai Shinagawa-ku, Tokyo
TEL	03-3784-8704
Homepage URL
Email	kokyuuki@med.showa-u.ac.jp

Sponsor
Institute	Department of Medicine, Division of Allergology and Respiratory Medicine, Showa University School of Medicine
Institute
Department

Funding Source
Organization	Astellas Pharma Inc Taisho Toyama Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	昭和大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 02 Day
Anticipated trial start date	2015 Year 01 Month 30 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 29 Day
Last modified on	2016 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018812