Unique ID issued by UMIN | UMIN000008010 |
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Receipt number | R000009420 |
Scientific Title | Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia. |
Date of disclosure of the study information | 2012/05/23 |
Last modified on | 2017/01/30 12:52:00 |
Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia.
Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy (YCRG0008)
Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia.
Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy (YCRG0008)
Japan |
Pneumonia
Pneumology |
Others
NO
To compare anti-inflammatory effects and efficacy of beta-lactum plus intravenous azithromycin with beta-lactum plus levofloxacin in moderate to severe bacterial peumonia patients
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Reduction rates of serum IL-8 levels over time
(1) Changes in biomarkers measured during treatment
(2) Recovery rates of acquired pneumonia in each treatment group
(3) Microbiological effective rates in each treatment group
(4) Survival rates of patients on 30 days after each treatment
(5) Evaluation of adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
Treatment group:
Sequential administration of
beta-lactam plus azithromycin (500 mg for 120 min).
Treatment to be continued if there was no improvement in inflammatory responses and radiological findings .
Blood samplings on day0, day3, day5, day7 and day10.
Sputum cultures taken before and after each treatment.
If needed, pharyngeal swab and urine antigen tests etc.
Control group:
Sequential administration of
beta-lactam plus levofloxacin (500 mg for 60 min).
Treatment to be continued if there was no improvement in inflammatory responses and radiological findings .
Blood samplings on day0, day3, day5, day7 and day10.
Sputum cultures taken before and after each treatment.
If needed, pharyngeal swab and urine antigen tests etc.
16 | years-old | <= |
85 | years-old | > |
Male and Female
Inclusion criteria:
(1) Patient with be from 16 to 85-years old
(2) Moderate to severe pneumonia patents that needed to be hospitalized
(3) Patient without long-term oral steroid treatment
(4) Patients who are agreed with the study enrollment
Exclusion criteria:
(1) Patients with hypersensitivity to azithromycin, macrolide or ketolide antibiotic agents
(2) Patients with hypersensitivity to levofloxacin or ofloxacin
(3) Patients with liver dysfunction (AST, ALT, and total bilirubin > 3 times upper limit of normal range)
(4) Patients with severe renal dysfunction (creatinine clearance <30 mL/min)
(5) Patients with prior or current evidence of severe heart diseases (NYHA grade IV), congenital or sporadic prolongation of the QT interval, or receiving medications known to cause prolongation of the QT interval
(6) Patients with severe underlying diseases or complications that have the difficulties of the evaluations of drug efficacy
(7) Patients who require other systemic antibiotic treatments
(8)Patients by whom other antimicrobial drugs (internal use or injection) were prescribed for the patient exceeding 48 hours to this infection before investigational new drug trial drug medication
(9)Patients with gastrointestinal disorders disrupting drug absorption
(10)Pregnant women or females with childbearing potential
(11) Any other condition which, in the opinion of the investigator, would make the subject unsuitable for enrollment
80
1st name | |
Middle name | |
Last name | Takeshi Kaneko |
Yokohama City University Medical Center
Respiratory Disease Center
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
takeshi@med.yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Masaharu Shinkai |
Yokohama City University Medical Center
Respiratory Disease Center
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
shinkai@yokohama-cu.ac.jp
Yokohama City University Medical Center
None
Self funding
NO
横浜市立大学附属市民総合医療センター(神奈川県)
大和市立病院(神奈川県)
神奈川県立がんセンター(神奈川県)
藤沢市民病院(神奈川県)
関東労災病院(神奈川県)
横浜南共済病院(神奈川県)
横浜市立大学附属病院(神奈川県)
防衛医科大学校病院(埼玉県)
国立病院機構横浜医療センター(神奈川県)
横浜栄共済病院(神奈川県)
済生会横浜市南部病院(神奈川県)
横浜船員保険病院(神奈川県)
茅ヶ崎市立病院(神奈川県)
横須賀市立市民病院(神奈川県)
2012 | Year | 05 | Month | 23 | Day |
Unpublished
Terminated
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 22 | Day |
2017 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009420
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