UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010722
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Obsterics 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
Email

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
Email

Sponsor
Institute Department of Clinical Infectious Diseases, Aichi Medical Univertisy Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.