UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035994 |
|---|---|
| Receipt number | R000040283 |
| Scientific Title | Efficacy of multiplex PCR among children with respiratory infection |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2023/02/27 12:52:20 |
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Basic information
Public title
Efficacy of multiplex PCR among children with respiratory infection
Acronym
Efficacy of multiplex PCR among children with respiratory infection
Scientific Title
Efficacy of multiplex PCR among children with respiratory infection
Scientific Title:Acronym
Efficacy of multiplex PCR among children with respiratory infection
Region
| Japan |
Condition
Condition
Respiratory infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify safety, efficacy, reduction in antibiotics use, and cost effectiveness of multiplex PCR among children with respiratory infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of antibiotics administration within 14 days of admission.
Key secondary outcomes
Duration of mechanical ventilation, length of intensive care unit and hospital stay, mortality, complications due to antibiotics, and infectious complications within 28 days of admission. Proportion of broad antibiotics use, and cost of antibiotics within 14 days of admission.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
We recommend not to use antibiotics when all the followings are satisfied: 1) viral pathogen is proved by multiplex PCR, 2) patient is respiratory and circulatory stable, and 3) white blood cell count <13.0x103/mm3 and CRP <5.0mg/dL. However, initiation or selection of antibiotics are decided according to physicians' judgement.
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
| 216 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
We include patients admit to the PICU or high care unit with diagnosis of respiratory infection according to respiratory symptoms, hypoxia, or radiograph, and who required oxygen.
Key exclusion criteria
We exclude patients with immunodeficiency or who received therapeutic interventions for infections within the previous 1 month.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hatachi |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Intensive Care Medicine
Zip code
594-1101
Address
Murodo-cho 840, Izumi-City, Osaka 594-1101, Japan
TEL
0725-56-1220
hatachi@mch.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hatachi |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Intensive Care Medicine
Zip code
594-1101
Address
Murodo-cho 840, Izumi-City, Osaka 594-1101, Japan
TEL
0725-56-1220
Homepage URL
hatachi@mch.pref.osaka.jp
Sponsor or person
Institute
Osaka Women's and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Osaka Women's and Children's Hospital
Address
Murodo-cho 840, Izumi-City, Osaka, 594-1101 Japan
Tel
0725-56-1220
hatachi@mch.pref.osaka.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
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/pccmjournal/Fulltext/2021/12000/Application_of_Multiplex_Polymerase_Chain_R
Publication of results
Unpublished
Result
URL related to results and publications
https://journals.lww.com/pccmjournal/Fulltext/2021/12000/Application_of_Multiplex_Polymerase_Chain_R
Number of participants that the trial has enrolled
181
Results
There were no differences in antibiotic use (84% vs 75%; p = 0.14), broad-spectrum antibiotic use (33% vs 34%; p = 0.91), or the duration of antibiotic use within 14 days of admission (6.0 vs 7.0 d; p = 0.45) between the pre- and postmultiplex polymerase chain reaction periods.
Results date posted
| 2023 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ninety-six and 85 children were enrolled during the pre- and postmultiplex polymerase chain reaction periods, respectively. Rapid antigen tests identified pathogens in 22% of the children (n = 21) during the premultiplex polymerase chain reaction period, whereas rapid antigen tests and/or multiplex polymerase chain reaction testing identified pathogens in 67% of the children (n = 57) during the postmultiplex polymerase chain reaction period (p < 0.001).
Participant flow
Consecutive children with respiratory infections who were admitted to the PICU between December 2017 and November 2018 (premultiplex polymerase chain reaction period) and between March 2019 and February 2020 (postmultiplex polymerase chain reaction period).
Adverse events
Nothing
Outcome measures
The primary outcome was the pathogen identification rate during the pre- (RATs only) and post-mPCR (RATs and mPCR testing) periods. Conventional RATs were available for six pathogens. mPCR testing was performed using the FilmArray respiratory panel (BioFire Diagnostics, Salt Lake City, UT) (3), which included 17 viruses and three bacterial pathogens (Supplemental Digital Content 1, https://links.lww.com/PCC/B831).
The secondary outcome was the use and duration of antibiotics used within 14 days of admission to the PICU, before and after the implementation of mPCR testing. During the post-mPCR period, reduced antibiotic use was recommended for a stable patient depending on the virus species and laboratory test results (Supplemental Digital Content 1, https://links.lww.com/PCC/B831).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040283
