UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010722 |
|---|---|
| Receipt number | R000012530 |
| Scientific Title | The clinical and bacteriological efficacy of Doripenem (DRPM) in patients with infections by Extended-spectrum beta-lactamase (ESBLs)-producing strains: non-randomized, open, label, multi-centre study. |
| Date of disclosure of the study information | 2013/05/14 |
| Last modified on | 2015/09/29 14:01:28 |
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Basic information
Public title
The clinical and bacteriological efficacy of Doripenem (DRPM) in patients with infections by Extended-spectrum beta-lactamase (ESBLs)-producing strains: non-randomized, open, label, multi-centre study.
Acronym
The clinical and bacteriological efficacy of DRPM in patients with infections by ESBL-producing strains.
Scientific Title
The clinical and bacteriological efficacy of Doripenem (DRPM) in patients with infections by Extended-spectrum beta-lactamase (ESBLs)-producing strains: non-randomized, open, label, multi-centre study.
Scientific Title:Acronym
The clinical and bacteriological efficacy of DRPM in patients with infections by ESBL-producing strains.
Region
| Japan |
Condition
Condition
Adaptable infections of DRPM
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Infectious disease | Surgery in general | Obstetrics and Gynecology |
| Oto-rhino-laryngology | Urology | Neurosurgery |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of DRPM in patients with infections by ESBL-producing strains.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical efficacy in patients with infections by ESBL-producing strains at the end of medication.
Key secondary outcomes
Clinical efficacy in patients with infections by ESBL-producing strains at 7 days of medication.
Bacteriological efficacy in ESBL-producing strains at the end of medication.
And a comparison between above ESBL and non-ESBL (include patients without isolates pathogenic strains).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients or guardian of the patients with informed consent.
2) Age: over 16 years (at the time the informed consent form is signed).
3) Gender: Male or female
4) In patients.
5) Adaptable infections of DRPM.
6) Patients of the following criteria (a) or (b) at the time the informed consent form is signed: (a) The possibility of infection by ESBL-producing strains because of past episodes etc,. (b) The proving of ifections by ESBL-producing strains because of drug sensitivity test etc,.
Key exclusion criteria
1) Hisotry of spilepsy. Neurological symptoms with convulsions.
2) History of hypersensitivity, allergy or serious adverse drug event caused by beta-lactam antibiotics.
3) Woman who are pregnant and breast-feeding or suspected to be pregnant.
4) Any other patients whose condition is inappropriate for the evaluation of this clinical study as judged by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Yamagishi |
Organization
Aichi Medical University Hospital
Division name
Department of Clinical Infectious Diseases
Zip code
Address
1-1, Yazakokarimata, Nagakute-city, Aichi, 480-1195, Japan
TEL
0561-62-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Yamagishi |
Organization
Aichi Medical University Hospital
Division name
Department of Clinical Infectious Diseases
Zip code
Address
1-1 Yazakokarimata,Nagakute-city,Aichi,480-1195, Japan
TEL
0561-62-3311
Homepage URL
Sponsor or person
Institute
Department of Clinical Infectious Diseases, Aichi Medical Univertisy Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2013 | Year | 05 | Month | 14 | 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
| 2012 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-randomized, open-label, multi-centre study.
Management information
Registered date
| 2013 | Year | 05 | Month | 14 | Day |
Last modified on
| 2015 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012530
