UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002096 |
|---|---|
| Receipt number | R000002543 |
| Scientific Title | A Switch Therapy for Community-acquired Pneumonia: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2011/07/22 09:39:27 |
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Basic information
Public title
A Switch Therapy for Community-acquired Pneumonia: A Randomized Controlled Trial
Acronym
A Switch Therapy for Community-acquired Pneumonia.
Scientific Title
A Switch Therapy for Community-acquired Pneumonia: A Randomized Controlled Trial
Scientific Title:Acronym
A Switch Therapy for Community-acquired Pneumonia.
Region
| Japan |
Condition
Condition
Community-acquired pneumonia in adults
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of oral garenoxacin (GRNX) compared with parenteral antibacterials for the treatment of community-acquired pneumonia in adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Clinical and bacteriologic efficacy, chest radiograph resolution, and patient satisfaction in oral therapy and parenteral therapy.
Key secondary outcomes
Analysis of the cost-effectiveness of oral therapy and parenteral therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Four-day oral garenoxacin once daily after intravenous ampicillin/sulbactam once daily for 3 days
Interventions/Control_2
Four-day intravenous ampicillin/sulbactam once daily after intravenous Ampicillin/sulbactam once daily for 3 days
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) Adult patients with community-acquired pneumonia requiring hospitalisation and parenteral antibiotic therapy.
2) PSI II-IV
3) Patients after obtaining signed informed consent.
Key exclusion criteria
1) Patients with episodes of aspiration
2) Patients with thoracic cavity drainage due to lung suppuration or empyema
3) Obstructive pneumonia due to airway obstruction
4) Legionella, MRSA, and P. aeruginosa are causative microorganism.
5) Patients who are treated with more than 10 mg of steroid
6) Patients with infections due to causative microorganism which is regarded as being ineffective to garenoxacin
7) Patients with a history of allergy/severe adverse effect to quinolone antibacterial agents or B-lactum antibacterial agents
8) Patients with a history of seizure/epilepsy or patients who are taking antiepilepsy drug
9) Patients with severe hepatic impairment, renal impairment, and cardiac impairment
10) Pregnancy/lactation
11) Patients who are regarded as inadequate subject by physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kohno |
Organization
Nagasaki University
Division name
School of Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7418
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsunori Yanagihara |
Organization
Nagasaki University
Division name
School of Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7418
Homepage URL
k-yanagi@nagasaki-u.ac.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
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 19 | Day |
Last modified on
| 2011 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002543
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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