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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003896
Receipt No. R000004592
Scientific Title Randomized Controlled multi-center Trial for Nursing and Health care associated pneumonia with SBT/ABPC, TAZ/PIPC and DRPM
Date of disclosure of the study information 2010/07/15
Last modified on 2015/08/05

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Basic information
Public title Randomized Controlled multi-center Trial for Nursing and Health care associated pneumonia with SBT/ABPC, TAZ/PIPC and DRPM
Acronym Niigata HCAP study
Scientific Title Randomized Controlled multi-center Trial for Nursing and Health care associated pneumonia with SBT/ABPC, TAZ/PIPC and DRPM
Scientific Title:Acronym Niigata HCAP study
Region
Japan

Condition
Condition healthcare-associated pneumonia
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hypotheses
1)When SBT/ABPC, the treatment drug recommended for moderate community-acquired pneumonia in the current guideline The Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults, was set as a control drug, which is inferior to TAZ/PIPC and DRPM in the therapeutic effects to treat healthcare-associated pneumonia (HCAP).
2) TAZ/PIPC and DRPM give comparable therapeutic efficacy in HCAP patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes To compare the clinical efficacy among 3 treatment groups at the end of treatment.
Key secondary outcomes 1. Life prognosis at 30 days after completion of treatment
2. Ratio of drug-resistant strain of bacteria involvement in HCAP
3. Duration of hospitalization
4. Costs required for antibacterial agents administered until pneumonia was resolved

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 considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SBT/ABPC group
Interventions/Control_2 TAZ/PIPC group
Interventions/Control_3 DRPM group
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 Patients who have at least one of the following backgrounds (i) to (iv), and meet the following (1) to (3):
(i) A history of hospitalization within 90 days prior to the onset of pneumonia
(ii) Transferred from nursing-care facilities (including those who use psychiatric ward)
(iii) Aged patients who need a nursing service(iv)Outpatients who continuously need a intravenus drug therapy (anti-biotics, anti-cancer drug, immunosuprressive drug etc.) (1) Patients with A-DROP moderate bacterial pneumonia
(2)Patients who are deemed to be evaluable by a physician in charge
(3) Hospitalized patients who are able to submit informed consent and are willing to participate in the study
(Informed consent could be acquired from representative)
Key exclusion criteria Apparent massive aspiration (chemical pneumonia due to gastric acid is assumed)
Patients with a history of allergy to the study drug or past history of adverse reactions
Patients with serious hepatic or renal dysfunction
Hepatic dysfunction with AST and ALT elevation at least twice the institutional standard
For renal dysfunction at least CKD stage 4 (Japanese Society of Nephrology CKD guideline 2009)
Patients with a past history of epilepsy, or those who have central nervous system disease with convulsions at the start of the study
Pregnant women, women who are possibly be pregnant, and nursing women
Patients with a causative agent not sensitive to the study drug and have been found to be with infection due to strains that are apparently considered not to be sensitive (MRSA, S.maltophilia, legionella group, etc.)
Patients who require coadministration of prohibited concomitant drugs
Patients with lung cancer who are with apparent causation of airway obstruction
Target sample size 510

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinari TANABE
Organization Niigata University Medical & Dental Hospital
Division name Division of Infection Control and Prevention
Zip code
Address 1-754 Asahimachi-dori, Niigata 951-8510,Japan
TEL +81-25-227-2200
Email y-tanabe@med.niigata-u.a.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinari TANABE
Organization Niigata University Medical & Dental Hospital
Division name Division of Infection Control and Prevention
Zip code
Address 1-754 Asahimachi-dori, Niigata 951-8510,Japan
TEL +81-25-227-2200
Homepage URL
Email y-tanabe@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Medical & Dental Hospital
Institute
Department

Funding Source
Organization Niigata University Medical & Dental Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 県立坂町病院(新潟県)Niigata prefectural Salamachi Hospital
県立新発田病院(新潟県)Niigata prefectural Shibata Hospital
県立津川病院(新潟県)Niigata prefectural Tsugawa Hospital
厚生連豊栄病院(新潟県)Niigata kouseiren Toyoisaka Hospital
信楽園病院(新潟県)Niigata Shinrakuen Hospital
済生会新潟第二病院(新潟県)Saiseikai Niigata Daini Hospital         
新潟市民病院(新潟県)Niigata city General Hospital           
白根健生病院(新潟県)Shirone kensei Hospital
三条総合病院(新潟県)Niigata kouseiren Sanjo General Hospital           
県立吉田病院(新潟県)Niigata prefectural Yoshida Hospital            
長岡赤十字病院(新潟県)Nagaoka Red Cross Hospital
厚生連長岡中央総合病院(新潟県)Niigata kouseiren Nagaoka Chuo General Hospital
厚生連刈羽群総合病院(新潟県)Niigata kouseiren Kariwa-gun General Hospital     
県立柿崎病院(新潟県)Niigata prefectural Kakizaki Hospital            
県立六日町病院(新潟県)Niigata prefectural Muikamachi Hospital
県立中央病院(新潟県)Niigata prefectural Central Hospital            
県立妙高病院(新潟県)Niigata prefectural Myoukou Hospital            
厚生連糸魚川病院(新潟県)Niigata Kouseiren Itoigawa Hospital
厚生連佐渡総合病院(新潟県)Niigata Kouseiren Itoigawa sogo Hospital
両津市民病院(新潟県)Sado City Ryoutsu Hospital

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 15 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
2010 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2013 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 09 Day
Last modified on
2015 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004592

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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