UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036083 |
|---|---|
| Receipt number | R000041076 |
| Scientific Title | Quantified anlysis of once-daily therapy for streptococcal pharyngitis with amoxicillin by real time PCR |
| Date of disclosure of the study information | 2019/03/12 |
| Last modified on | 2019/03/08 10:59:57 |
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Basic information
Public title
Quantified anlysis of once-daily therapy for streptococcal pharyngitis with amoxicillin by real time PCR
Acronym
Quantified anlysis of once-daily therapy for streptococcal pharyngitis with amoxicillin by real time PCR
Scientific Title
Quantified anlysis of once-daily therapy for streptococcal pharyngitis with amoxicillin by real time PCR
Scientific Title:Acronym
Quantified anlysis of once-daily therapy for streptococcal pharyngitis with amoxicillin by real time PCR
Region
| Japan |
Condition
Condition
acute pharyngeal tonsillitis
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of once-daily amoxicillin in the treatment of streptococal pharyngitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative PCR tests of pharyngeal swab samples collected three time points: during visit 1 (before the start of the treatment), visit 2 (1 to 3 days after the treatment), and visit 3 (9 to 11 days after the treatment)
Key secondary outcomes
The clinical course and result of culture tests after the treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Amoxicillin was administered at a dose of 40 to 50 mg/kg/day with an upper limit of 1,000 mg/day, divided into onec-daily doses, for 10 days.
Interventions/Control_2
Amoxicillin was administered at a dose of 40 to 50 mg/kg/day with an upper limit of 1,000 mg/day, divided into twice or three times daily doses, for 10 days.
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
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study subjects were suspected of having acute pharyngeal tonsillitis due to Streptococcus pyogenes infection. Clinical diagnoses were made on the basis of reference symptoms, such as fever, sore throat, malaise, and headache with acute onset, whereas the physical findings that suggested the infection included prominent pharyngeal redness, tonsil swelling with exudate, and cervical lymphadenopathy. The study subjects underwent rapid antigen test using a throat swab and isolation culture tests, in which Streptococcus pyogenes was detected.
Key exclusion criteria
Patients with a history of penicillin allergies or those who received antibacterial drugs within the previous 4 weeks were excluded from this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Nakao |
Organization
Juntendo University
Division name
Department of Pediatrics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
aknakao@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Nakao |
Organization
Juntendo University
Division name
Department of Pediatrics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
aknakao@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Health Public Corporation Toshima 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
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 | 12 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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
| 2019 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041076
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
