UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054606 |
|---|---|
| Receipt number | R000061976 |
| Scientific Title | Observational study of medical treatment for acute osteomyelitis and pyogenic arthritis |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/12/06 11:37:05 |
* 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
Observational study of medical treatment for acute osteomyelitis and pyogenic arthritis
Acronym
Observational study of medical treatment for acute osteomyelitis and pyogenic arthritis
Scientific Title
Observational study of medical treatment for acute osteomyelitis and pyogenic arthritis
Scientific Title:Acronym
Observational study of medical treatment for acute osteomyelitis and pyogenic arthritis
Region
| Japan |
Condition
Condition
acute osteomyelitis, septic arthritis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In acute osteomyelitis and septic arthritis, comparing the group that underwent short-term intravenous therapy (including treatment initiation up to day 6) followed by oral therapy according to the ESPID guideline with the group that received the intravenous therapy for 7 days or more, demonstrate cure rates with frequency and confidence interval widths using retrospective and prospective observational studies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cure rate at 6 months from the start of treatment, meaning the absence of symptoms and signs of acute osteomyelitis and septic arthritis, and no requirement of additional antimicrobial therapy due to recurrence.
Key secondary outcomes
Base
Study type
Observational
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
| 1 | months-old | <= |
Age-upper limit
| 19 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Diagnosed with acute osteomyelitis or septic arthritis at a single site based on fever, local symptoms, and imaging findings, or diagnosed with both acute osteomyelitis and septic arthritis.
2 Aged over 1 month and under 19 years old.
3 Those who showed treatment responsiveness* to initial treatment within 5 days after treatment initiation**.
4 Cases with no positive blood culture beyond 2 days after treatment initiation**.
5 Microorganisms identified from blood, joint fluid, and pus, with susceptibility.
6 Able to take medication orally or through tube feeding, and the drug can be absorbed from the gastrointestinal tract.
*Treatment responsiveness: Determined when fever resolves and local redness, swelling, and pain improve compared to before treatment initiation.
**Treatment initiation: Day 1 is considered as the day of the second administration of initial antimicrobial therapy.
Key exclusion criteria
1 Those with causative microorganisms resistant to MRSA, PRSP, or other drug-resistant or acid-fast bacteria.
2 Those diagnosed as chronic osteomyelitis (with symptoms present for over 2 weeks before treatment initiation, etc.).
3 Those diagnosed with congenital or acquired immunodeficiency syndrome.
4 Cases of arthritis or osteomyelitis following trauma, surgery, or foreign body placement.
5 Cases of non-hematogenous arthritis or osteomyelitis due to direct extension from primary infectious foci.
6 Those who opted not to disclose information about this study and indicated refusal.
7 Others deemed unsuitable as subjects by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Miyashita |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of infectious disease
Zip code
183-8561
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo
TEL
042-300-5111
aki1002.miya1993@gmail.com
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Miyashita |
Organization
Tokyo Metropolitan Children's medical center
Division name
Division of infectious disease
Zip code
183-8561
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo
TEL
042-300-5111
Homepage URL
aki1002.miya1993@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Chidren's Medical Center
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's medical center
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo
Tel
042-300-5111
sn_erb@tmhp.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
| 2024 | Year | 07 | Month | 01 | 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
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061976
