UMIN-CTR Clinical Trial

Public title

Clinical efficacy of garenoxacin for treatment of bacterial respiratory infection secondary to chronic respiratory disease

Acronym

GARIREO study

Scientific Title

Clinical efficacy of garenoxacin for treatment of bacterial respiratory infection secondary to chronic respiratory disease

Scientific Title:Acronym

GARIREO study

Region

Japan

Condition

Bacterial respiratory infection secondary to chronic respiratory disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hironori Sagara

Organization

Showa University School of Medicine

Division name

Department of Medicine, Division of Allergology and Respiratory Medicine

Zip code

Address

1-5-8 Hatanodai Shinagawa-ku, Tokyo

TEL

03-3784-8704

Email

kokyuuki@med.showa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Akihiko Tanaka

Organization

Showa University School of Medicine

Division name

Department of Medicine, Division of Allergology and Respiratory Medicine

Zip code

Address

1-5-8 Hatanodai Shinagawa-ku, Tokyo

TEL

03-3784-8704

Homepage URL

Email

kokyuuki@med.showa-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

Astellas Pharma Inc
Taisho Toyama Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

昭和大学病院（東京都）

Date of disclosure of the study information

2015

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

10

Month

02

Day

Date of IRB

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

Other related information

Registered date

2015

Year

01

Month

29

Day

Last modified on

2016

Year

09

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018812