UMIN-CTR Clinical Trial

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

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014292
Receipt No. R000016642
Scientific Title Study of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port
Date of disclosure of the study information 2014/07/28
Last modified on 2016/06/17

* 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 Study of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port
Acronym Study of antimicrobial lock therapy
Scientific Title Study of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port
Scientific Title:Acronym Study of antimicrobial lock therapy
Region
Japan

Condition
Condition Case of catheter-related bloodstream infection in totally implantable central venous port
Classification by specialty
Infectious disease Surgery in general Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to assess the efficacy and safety of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the efficacy of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port.
Key secondary outcomes To evaluate the safety of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 3mL of mixed drug solution (Caspofungin 2.5mg/mL and Daptomycin 50mg/mL) was inserted to the central venous catheter port. Insertion was performed by 24 hours.
When the result of blood culture was detected, the drug solution was changed (Caspofungin 2.5mg/mL, Daptomycin 50mg/mL, or amikacin sulfate 100mg/mL). Insertion was performed by 24 hours for 14 days from the first lock therapy.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who underwent home parenteral nutrition by totally implantable central venous port.
2. fever more than 38.0 degree.
3. catheter-related bloodstream infection is suspected.
4. No severe complication by sepsis. General condition is good.
5. No allergy for antimicrobial drugs which will be used in this study.
Key exclusion criteria 1.Patients with severe sepsis
2.Patients who underwent lock therapy for bacterial infection within 3 months
3.Patients who underwent lock therapy for fungal infection
4.Patients with pregnancy
5.Patients who doctors regarded as inadequate to participate this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Watanabe
Organization Tohoku University Hospital
Division name Gastrointestinal Surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7205
Email k-wata@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Watanabe
Organization Tohoku University Hospital
Division name Gastrointestinal Surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7205
Homepage URL
Email k-wata@surg1.med.tohoku.ac.jp

Sponsor
Institute Division of Gastrointestinal Surgery, Tohoku University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Division of Gastrointestinal Surgery, Tohoku University Hospital
Organization
Division
Category of Funding Organization Other
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
2014 Year 07 Month 28 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 Enrolling by invitation
Date of protocol fixation
2014 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 17 Day
Last modified on
2016 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016642


Contact us.