UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010901 |
|---|---|
| Receipt number | R000012668 |
| Scientific Title | A randomized comparative study of efficacy of intra-arterial injection of daptomycin for patients with antibiotic-resistant bacterial infection in lower limbs |
| Date of disclosure of the study information | 2013/06/07 |
| Last modified on | 2013/06/07 15:48:14 |
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Basic information
Public title
A randomized comparative study of efficacy of intra-arterial injection of daptomycin for patients with antibiotic-resistant bacterial infection in lower limbs
Acronym
Effect of intra-arterial injection of daptomycin on antibiotic-resistant bacterial infection
Scientific Title
A randomized comparative study of efficacy of intra-arterial injection of daptomycin for patients with antibiotic-resistant bacterial infection in lower limbs
Scientific Title:Acronym
Effect of intra-arterial injection of daptomycin on antibiotic-resistant bacterial infection
Region
| Japan |
Condition
Condition
Patients requiring surgical treatment for MRSA (Methicillin-resistant Staphylococcus aureus) infection in lower limbs
Classification by specialty
| Infectious disease | Orthopedics | Anesthesiology |
| Plastic surgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the duration of treatment by femoral artery injection of antibiotics before surgery for MRSA infection in lower limbs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Time to normalize body temperature after surgery, Time to normalize the number of leukocytes and CRP levels, Time to normalize sedimentation rate, Length of stay in hospital
Key secondary outcomes
Daptomycin concentration of femoral venous blood after intra-arterial injection of daptomycin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intra-arterial injection of antibiotics before surgery
Interventions/Control_2
Intravenous injection of antibiotics before surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requiring surgical treatment for MRSA infection in lower limbs
(gonarthritis, podarthritis, lower limbs osteomyelitis, lower limbs soft tissue infection)
Key exclusion criteria
1.No written informed consent
2.Daptomycin allergy
3.Possible pregnancy
4.Patients ineligible to the study based on investigator's decision
5.MRSA non-sensitive to daptomycin
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Haraga |
Organization
Fukuoka University
Division name
Department of Anesthesiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Haraga |
Organization
Fukuoka University
Division name
Department of Anesthesiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
http://www.hop.fukuoka-u.ac.jp/rinshou/doctor/shounin.html
haraga_i@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Department of Anesthesiology
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
None
Name of secondary funder(s)
None
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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 07 | 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
| 2013 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 07 | 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
| 2013 | Year | 06 | Month | 07 | Day |
Last modified on
| 2013 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012668
