UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010036 |
|---|---|
| Receipt number | R000011752 |
| Scientific Title | A clinical study of pazufloxacin administered at a dose of 1,000mg twice daily in patients with sepsis due to urogenital infection |
| Date of disclosure of the study information | 2013/02/14 |
| Last modified on | 2013/08/28 13:55:45 |
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Basic information
Public title
A clinical study of pazufloxacin administered at a dose of 1,000mg twice daily in patients with sepsis due to urogenital infection
Acronym
A clinical study of pazufloxacin in patients with sepsis due to urogenital infection
Scientific Title
A clinical study of pazufloxacin administered at a dose of 1,000mg twice daily in patients with sepsis due to urogenital infection
Scientific Title:Acronym
A clinical study of pazufloxacin in patients with sepsis due to urogenital infection
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical efficacy and safety of pazufloxacin in patients with sepsis due to urogenital infection are evaluated with antimicrobial agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical outcome and microbiological outcome of sepsis at the end or discontinuation of administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pazufloxacin is administered at a dose of 1000mg twice daily.Time course of intravenous drip infusion is over 1hour.The administration is started wuthin 1 hr at the diagnosis of sepsis. Assessment shall be made 3~5days after pyretolysis or control of complications. It can end,when a doctor accepts as recovery.Later switched to an oral antimicrobial agent is approved to a doctor,after the judgment of clinical outcome and microbiological outcome of sepsis at the end of mediation with pazufloxacin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(Entry criteria)
The patients diagnose clinically sepsis due to pyelonephritis,acute bacterial prostatitis and acute epididymitis with positive blood culture or suspective.SIRS can be diagnosed when two or more of these criteria are present.
1.Body temperature:greater than 38
orless than 36
2.Heart rate: greater than 90 beats per minute
3.Tachypnea(high respiratory rate):
greater than 20 breaths per minute or an arterial partial presure of carbon dioxide less than 32mmHg
4.White blood cell count:greater than 12000 cells/mm3 or the presence of greater than 10% immature neutrophils
band forms
Procalsitonin is keasured as possible according to reference of the diagnosis of sepsis.
Key exclusion criteria
(Exclusion criteria)
Complicated pyelonephritis with catheter detention (exclusion an indwelling catheter in the living body)
Acute epididymitis with Chlamydia.
Bacterial count Viable bacterial count before initiation of medication less than 104CFU/ml(medstream urine less than 105CFU/ml)
Pyuria: Patients meeting any of the following criteria
Prescribed equipment that uses non-centrifuged urine less than 10WBCs/ul
Counting chamber method that uses noncentrifuged urine less than 10WBCs/mm3
Uinary test strip that uses nonentrifuged urine negative
Microscopy of urinary sediment less than 5WBCs/hpf
(Omission criteria)
1 Patients who has an anamnesis of hypersensitivity to the ingredient of this agent
2 Patients who has a critical obstacle of heaet,liver or kidney
3 Patients with the anamnesis of a spasm or epilepsy
4 Pregnant women or patients at a risk of pregnancy
5 Patients who are already improved with an antimicrobial agent before PZFX medication
6 Patients who admitted that a doctor in charge is unsuitable
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyohito Ishikawa |
Organization
FUJITA HEALTH UNIVERSITY
Division name
Urology
Zip code
Address
1-98,dengakugakubo,kutsukake-cho,toyoake,Aichi,470-1192Japan,
TEL
0562-93-2000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyohito Ishikawa |
Organization
FUJITA HEALTH UNIVERSITY
Division name
Urology
Zip code
Address
TEL
0562-93-2000
Homepage URL
Sponsor or person
Institute
NPO CREC net
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
Japanese UTI Research Group
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
坂文種報徳会病院、名古屋掖済会病院、南生協病院、中津川市民病院、浜松赤十字病院、平塚市民病院、静岡赤十字病院、UTI共同研究会関連大学：産業医科大学、岐阜大学、兵庫医科大学、神戸大学、岡山大学、鹿児島大学とその関連施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2013 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011752
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