UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005515 |
|---|---|
| Receipt number | 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 13:51:15 |
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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
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
shinkin@peath.co.jp
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006541
