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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010036
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute NPO CREC net
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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