Unique ID issued by UMIN | UMIN000003896 |
---|---|
Receipt number | 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 19:36:10 |
Randomized Controlled multi-center Trial for Nursing and Health care associated pneumonia with SBT/ABPC, TAZ/PIPC and DRPM
Niigata HCAP study
Randomized Controlled multi-center Trial for Nursing and Health care associated pneumonia with SBT/ABPC, TAZ/PIPC and DRPM
Niigata HCAP study
Japan |
healthcare-associated pneumonia
Pneumology | Infectious disease |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase IV
To compare the clinical efficacy among 3 treatment groups at the end of treatment.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as a block.
YES
Central registration
3
Treatment
Medicine |
SBT/ABPC group
TAZ/PIPC group
DRPM group
20 | years-old | <= |
Not applicable |
Male and Female
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)
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
510
1st name | |
Middle name | |
Last name | Yoshinari TANABE |
Niigata University Medical & Dental Hospital
Division of Infection Control and Prevention
1-754 Asahimachi-dori, Niigata 951-8510,Japan
+81-25-227-2200
y-tanabe@med.niigata-u.a.jp
1st name | |
Middle name | |
Last name | Yoshinari TANABE |
Niigata University Medical & Dental Hospital
Division of Infection Control and Prevention
1-754 Asahimachi-dori, Niigata 951-8510,Japan
+81-25-227-2200
y-tanabe@med.niigata-u.ac.jp
Niigata University Medical & Dental Hospital
Niigata University Medical & Dental Hospital
Other
Japan
NO
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
2010 | Year | 07 | Month | 15 | Day |
Unpublished
Completed
2010 | Year | 05 | Month | 11 | Day |
2010 | Year | 08 | Month | 01 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 08 | Month | 31 | Day |
2013 | Year | 09 | Month | 30 | Day |
2013 | Year | 10 | Month | 30 | Day |
2010 | Year | 07 | Month | 09 | Day |
2015 | Year | 08 | Month | 05 | Day |
Value
https://center6.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 |