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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036083
Receipt No. 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

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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
Email 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
Email aknakao@juntendo.ac.jp

Sponsor
Institute Juntendo University, Department of Pediatrics
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041076

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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