Unique ID issued by UMIN | UMIN000001348 |
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Receipt number | R000001639 |
Scientific Title | Open-label randomized comparative study of clindamycin vs. ampicillin/sulbactam in adults with mild aspiration pneumonia |
Date of disclosure of the study information | 2008/09/30 |
Last modified on | 2021/09/12 11:32:43 |
Open-label randomized comparative study of clindamycin vs. ampicillin/sulbactam in adults with mild aspiration pneumonia
clindamycin vs. ampicillin/sulbactam in mild aspiration pneumonia
Open-label randomized comparative study of clindamycin vs. ampicillin/sulbactam in adults with mild aspiration pneumonia
clindamycin vs. ampicillin/sulbactam in mild aspiration pneumonia
Japan |
aspiration pneumonia
Pneumology | Infectious disease | Geriatrics |
Others
NO
To compare clinical effectiveness between clindamycin and ampicillin/sulbactam in adult patient with mild aspiration pneumonia
Bio-equivalence
Confirmatory
Pragmatic
Phase IV
Clinical response at the end of therapy (days 11-14)
Early clinical response at days 4 and 7
Bacteriological response at days 11-14 (in bacteriologically evaluable patients)
Survival at day 30
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Medicine |
clindamycin 600mg dose parenteral infusion, every 12 hrs, for 4-14 days.
Dose may be adjusted when renal failure
ampicillin/sulbactam 3g dose parenteral infusion, every 12 hrs, for 4-14 days.
Dose may be adjusted when renal failure
15 | years-old | <= |
Not applicable |
Male and Female
(1) Hospital-admitted patients aged 15 yrs or more with a diagnosis of pneumonia and required initial parenteral treatment
(2) at least one of the following conditions (risk of aspiration): neurological disorders (cerebrovascular diseases, neuromuscular diseases, dementia, etc.), bed-ridden, oral/pharyngeal/throat disorder, gastro-esophageal disorder (esophageal diverticulum, achalasia, systemic sclerosis, esophageal cancer, GERD, post-gastrectomy (total or partial), hiatal hernia, etc.), usage of sedatives or hypnotics, insertion of a nasogastric tube, subjective or observed aspiration/choking/dysphagia, episode of vomiting.
(3) Radiological appearance of a new and/or progressive pulmonary infiltrate(s)
(4) At least two of the followings: cough, sputum or change of sputum character (increased volume and/or purulence), dyspnea, tachypnea, abnormal breathing sound (wheeze etc.), pleuritic chest pain, auscultatory findings on chest examination consistent with the lung infiltrate, documented body temperature > or =37.5C within the past 24hrs, rigors and/or chills, general malaise, and a WBC count of > or =10,000/mm3 or < 3,000/mm3.
(1) Hospital-acquired pneumonia
(2) Hospitalization within 60 days prior to the development of the symptom(s)
(3) Immunocompromising disease or receipt of immunopompromising therapy
(4) Active lung cancer
(5) Terminal illness
(6) Pregnancy or breast-feeding
(7) Known allergy to the indicated antibiotics
(8) Other infiltrative diseases (e.g. radiation pneumonitis, organizing pneumonia, drug-induced pneumonia, obstructive pneumonia etc.)
(9) Tuberculosis, fungal infection
(10) Empyema
80
1st name | |
Middle name | |
Last name | Isao Ito |
Kyoto University
Department of Respiratory Medicine
Shogoin-kawaharacho, Sakyo, Kyoto, 606-8507, Japan
075-751-3884
1st name | |
Middle name | |
Last name | Seizo Kadowaki |
Ono Municipal Hospital
Department of Internal Medicine
323 Nakamachi, Ono-city, 675-1332, Japan
0794-63-2020
Ono Municipal Hospital
Dainippon Sumitomo Pharma Co., Ltd.
Taisho Toyama Pharmaceutical Co., Ltd.
Profit organization
Japan
NO
2008 | Year | 09 | Month | 30 | Day |
Unpublished
Completed
2008 | Year | 06 | Month | 13 | Day |
2008 | Year | 09 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2013 | Year | 04 | Month | 30 | Day |
2008 | Year | 09 | Month | 02 | Day |
2021 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001639
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