UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046414 |
|---|---|
| Receipt number | R000049675 |
| Scientific Title | Association between statin use and daptomycin-related musculoskeletal adverse events: meta-analysis |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2021/12/19 11:18:01 |
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Basic information
Public title
Association between statin use and daptomycin-related musculoskeletal adverse events: meta-analysis
Acronym
Association between statin use and daptomycin-related musculoskeletal adverse events: meta-analysis
Scientific Title
Association between statin use and daptomycin-related musculoskeletal adverse events: meta-analysis
Scientific Title:Acronym
Association between statin use and daptomycin-related musculoskeletal adverse events: meta-analysis
Region
| Japan |
Condition
Condition
patients treated with daptomycin
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the association
between statin use and daptomycin-related musculoskeletal adverse events
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effects of statin use on DAP-related MAEs
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Reports examined the effects of statin use on DAP-related MAEs
Key exclusion criteria
Reports fulfilled criteria with letters/correspondence, case reports, relevant reviews, not controlled arm, unclear outcome.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Chuma |
Organization
Asahikawa Medical University
Division name
Department of Hospital Pharmacy and Pharmacology
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa
TEL
0166-69-3482
chuma-masayuki@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Chuma |
Organization
Asahikawa Medical University
Division name
Department of Hospital Pharmacy and Pharmacology
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa
TEL
0166-69-3482
Homepage URL
chuma-masayuki@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
0166-69-3482
chuma-masayuki@asahikawa-med.ac.jp
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
| 2021 | Year | 12 | Month | 20 | 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
4471
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct a meta-analysis to examine the effects of statin use on daptomycin-related musculoskeletal adverse events.
Management information
Registered date
| 2021 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049675
