UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012627 |
|---|---|
| Receipt number | R000014761 |
| Scientific Title | The Efficacy of sitafloxacin in the elderly patients with pneumonia (included Nursing and Healthcare-Associated Pneumonia, aspiration pneumonia: NHCAP and aspiration pneumonia) ; a randomized controlled study of sitafroxacin and garenoxacin |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2019/07/11 10:34:28 |
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Basic information
Public title
The Efficacy of sitafloxacin in the elderly patients with pneumonia (included Nursing and Healthcare-Associated Pneumonia, aspiration pneumonia: NHCAP and aspiration pneumonia) ; a randomized controlled study of sitafroxacin and garenoxacin
Acronym
A controlled study of sitafloxacin and garenoxacin in elderly patients with pneumonia
Scientific Title
The Efficacy of sitafloxacin in the elderly patients with pneumonia (included Nursing and Healthcare-Associated Pneumonia, aspiration pneumonia: NHCAP and aspiration pneumonia) ; a randomized controlled study of sitafroxacin and garenoxacin
Scientific Title:Acronym
A controlled study of sitafloxacin and garenoxacin in elderly patients with pneumonia
Region
| Japan |
Condition
Condition
Elderly patiens with pneumonia(including Nersing and healthcare-Associated Pneumonia,aspiration pneumonia)
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety for pneumonia in the elderly patients including Nursing and Healthcare-Associated Pneumonia, aspiration pneumonia between sitafloxacin and garenoxacin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical efficacy at 5-10 days after completing administration.(TOC:Tset of cure)
Key secondary outcomes
-Clinical efficacy 3 days after administration(early evaluation of drug efficacy)
-Clinical efficacy at completion of administration(EOT:End of treatment)
-Bacteriological response
-Bacteriological response to causative bacteria bacterium
-Bacteriological response to subject.
-Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of sitafloxacin
Interventions/Control_2
Administration of garenoxacin
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,The patient who acquired research participating consent by themselves
(or Legally acceptable
representative) by the document.
2,Acute infiltration are detected by chest X-ray or CT within the previous 48hours and the investigater suspects pneumonia from observation including at least one of the clinical symptoms/findings listed below
-cough
-Purulent sputum or increased purulence of sputum.
-Abnormal findings on auscultation and percussion (including moist rales, percussion dullness, and decreased breath sounds).
-Dyspnea or/and tachypnea
-Fevre(axllary temprerature);37 degrees or more in body temprature
Increased white blood cell count (>10,000/mm3), stab leucocytes >15%, or decreased white blood cell count(<4,500/mm3)
-Increase of CRP
-Hypoxemia
Key exclusion criteria
1, Patients who are prohibited to take either sitafloxacin or garenoxacin.
2,Low body weight (less than 40 kg).
3, Severe renal dysfunction (Ccr is less than 30 mL/min, or eGFR is less than 30 mL/min).
4,Patients with history of convulsant disease such as epilepsy.
5,Patients who took quinolones for current pneumonia
6,Intake of azithromycin (zithromax ) within 7 days before starting this study. But the patients who get treated with low-dose macrolide can be included.
7,Patients with severe underlying diseases such as advanced cancer, primary lung cancer, metastatic lung cancer, severe heart failure and severe respiratory failure.
8,Patients with cystic fibrosis, AIDS, pneumocystis pneumonia, or active pulmonary tuberculosis.
9,Patients with pneumonia severity of PORT score V.
10,Patients whose participation in the study may put them at disadvantages.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiga Miyazaki |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture
TEL
095-819-7273
moju516@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Miyazaki, Yoshifumi Imamura |
Organization
Nagasaki evaluation organization for clinical interventions
Division name
office
Zip code
Address
3-2-12, Uchikanda, Chiyodaku, Tokyo
TEL
03-5297-1052
Homepage URL
shinkin@peath.co.jp
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo Co.,Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
-Japan Community Health Care Organization Isahaya General Hospital
-The Japanese Red Cross Nagasaki
Genbaku Hospital
-The Japanese Red Cros Nagasaki
Genbaku Isahaya Hospital
-Sasebo city General hospital
-Sasebo Chuo Hospital
-NHO Ureshino Medical center
-Hokusho Central Hospital
-Aino Memorial Hospital
-National Hospital Nagasaki Medical Center
-Izumikawa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jiac-j.com/article/S1341-321X(19)30128-X/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.jiac-j.com/article/S1341-321X(19)30128-X/fulltext
Number of participants that the trial has enrolled
120
Results
The clinical cure rates (primary efficacy endpoint) at test of cure (5-10 days after the end of treatment) in the per-protocol (PP) population of sitafloxacin and garenoxacin groups were 88.5% (95% confidence interval: 76.6-95.6) and 88.9% (95% confidence interval: 77.4-95.8), respectively (p=1.00).
Results date posted
| 2019 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline characteristics were similar between the treatment groups among the 119 patients in the intention-to-treat (ITT) population. Their ages ranged from 65 to 98 years, with median ages of 77.0 years in the sitafloxacin group and 77.5 years in the garenoxacin group. The number of patients who had underlying diseases were 51 (87.9%) in the sitafloxacin group and 47 (77.0%) in the garenoxacin group.
Participant flow
Between March 26, 2014, and November 9, 2017, we enrolled 120 patients aged 65 years or older with pneumonia and the sitafloxacin group (59 patients) and garenoxacin group (61 patients) were randomly assigned. One patient in the sitafloxacin group withdrew before receiving the first treatment. Therefore, the ITT population consisted of 58 patients in the sitafloxacin group and 61 patients in the garenoxacin group. There was no violation of the inclusion/exclusion criteria, but there were 7 violations of the protocol (six exceeding the protocol-defined treatment period and one overdose of the study drug). Therefore, the PP population consisted of 55 patients in the sitafloxacin group and 57 patients in the garenoxacin group.
Adverse events
Adverse events were reported in 15 of 58 patients in the sitafloxacin group (25.9%) and in 18 of 61 patients in the garenoxacin group (29.5%). Of these, 12 adverse events (20.7%) in the sitafloxacin group and 17 adverse events (27.9%) in the garenoxacin group were considered drug-related, with hepatic dysfunction being common to both groups. There was no significant difference between the treatment groups in the incidence of adverse events or drug-related adverse events.
Outcome measures
The primary efficacy endpoint was the clinical cure rate at the test of cure. Secondary endpoints were the treatment effective rates on Day 4 and at the end of treatment, the bacteriological efficacy (bacteriological eradiation rates), and the safety outcomes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014761
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