UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005515
Receipt No. R000006541
Scientific Title Efficacy of respiratory quinolones for the treatment of community acquired pneumonia: a randomized controlled trial of moxifloxacin versus garenoxacin.
Date of disclosure of the study information 2011/04/27
Last modified on 2012/11/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of respiratory quinolones for the treatment of community acquired pneumonia: a randomized controlled trial of moxifloxacin versus garenoxacin.
Acronym Comparison between moxifloxacin and garenoxacin for the treatment of community acquired pneumonia.
Scientific Title Efficacy of respiratory quinolones for the treatment of community acquired pneumonia: a randomized controlled trial of moxifloxacin versus garenoxacin.
Scientific Title:Acronym Comparison between moxifloxacin and garenoxacin for the treatment of community acquired pneumonia.
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy and safety of moxifloxacin and garenoxacin for the treatment of community acquired pneumonia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clinical response at the test-of-cure (TOC) visit.
Key secondary outcomes 1. Clinical response at the 3rd day after the initiation of the treatment.
2. Clinical response at the end-of-treatment (EOT).
3. Bacteriological response at EOT.
4. Safety of drugs.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of moxifloxacin.
Interventions/Control_2 Administration of garenoxacin.
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 1.Patients who are 20 years of age or more.
2.Acute infiltrative changes are detected by chest X-ray or CT within the previous 48 hours and the investigator suspects community acquired pneumonia from observation including at least one of the clinical symptoms/findings listed below:
1)Cough.
2)Purulent sputum or increased purulence of sputum.
3)Abnormal findings on auscultation (including moist rales, dull breath sounds, and decreased breath sounds).
4)Dyspnea or/and tachypnea.
5)Fever (axillary temperature): >=37 degrees Celsius.
6)Increased white blood cell count (>10,000/mm3), stab leucocytes >15%, or decreased white blood cell count (<4,500/mm3).
7)Increase of CRP.
8)Hypoxemia.
3.Community acquired pneumonia with severity of PORT score I-IV (mild to moderate).
4.Patients who give their consent to participation in the study.
5.Patients who are able to take oral medications.
6.Patients, who took other medicine (except quinolones) more than 3 days and did not have any improvements, can participate in the study.
Key exclusion criteria 1.Patients who are prohibited to take either moxifloxacin or garenoxacin.
2.Low body weight (less than 40 kg).
3.Severe renal dysfunction (Ccr is less than 30 mL/min, or eGFR is less than 30 mL/min).
4.Patients with history of convulsant disease such as epilepsy.
5.Patients who took quinolones for current pneumonia.
6.Patients with episodes of apparent aspiration.
7.Patients with severe underlying diseases such as advanced cancer, primary lung cancer, metastatic lung cancer, severe heart failure and severe respiratory failure.
8.Patients with cystic fibrosis, AIDS, pneumocystis pneumonia, or active pulmonary tuberculosis.
9.Patients with pneumonia severity of PORT score V.
10.Patients whose participation in the study may put them at disadvantages.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Imamura
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7273
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagasaki evaluation organization for clinical interventions
Division name office
Zip code
Address
TEL
Homepage URL
Email shinkin@peath.co.jp

Sponsor
Institute Nagasaki evaluation organization for clinical interventions
Institute
Department

Funding Source
Organization Nagasaki evaluation organization for clinical interventions
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 長崎大学病院(長崎県)
健康保険諫早総合病院(長崎県)
日本赤十字社 長崎原爆病院(長崎県)
長崎市立病院成人病センター(長崎県)
長崎市立市民病院(長崎県)
日本赤十字社 長崎原爆諫早病院(長崎県)
佐世保市立総合病院(長崎県)
独立行政法人国立病院機構 嬉野医療センター(長崎県)
独立行政法人国立病院機構 長崎医療センター(長崎県)
医療法人白十字会 佐世保中央病院(長崎県)
特定・特別医療法人 雄博会 千住病院(長崎県)
地方独立行政法人 北松中央病院(長崎県)
医療法人栄和会 泉川病院(長崎県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 27 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 Completed
Date of protocol fixation
2011 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
2013 Year 07 Month 01 Day
Date trial data considered complete
2013 Year 09 Month 01 Day
Date analysis concluded
2013 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 26 Day
Last modified on
2012 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006541

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.