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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002096
Receipt No. 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

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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
Email

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
Email k-yanagi@nagasaki-u.ac.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 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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002543

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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