UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003771 |
|---|---|
| Receipt number | R000004295 |
| Scientific Title | A comparative study of the therapeutic efficacy of azithromycin and tosufloxacin against pediatric respiratory infection with Mycoplasma pneumoniae possessed macrolide-resistant gene. |
| Date of disclosure of the study information | 2010/06/17 |
| Last modified on | 2017/02/09 11:17:23 |
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Basic information
Public title
A comparative study of the therapeutic efficacy of azithromycin and tosufloxacin against pediatric respiratory infection with Mycoplasma pneumoniae possessed macrolide-resistant gene.
Acronym
Kawasaki Pediatric 1(KP1)
Scientific Title
A comparative study of the therapeutic efficacy of azithromycin and tosufloxacin against pediatric respiratory infection with Mycoplasma pneumoniae possessed macrolide-resistant gene.
Scientific Title:Acronym
Kawasaki Pediatric 1(KP1)
Region
| Japan |
Condition
Condition
Mycoplasma infection
Classification by specialty
| Pneumology | Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relation between therapeutic efficacy of azithromycin and tosufloxacin against pediatric respiratory infection with Mycoplasma pneumoniae and macrolide-resisted gene will be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The clinical response of azithromycin and tosufloxacin treatment.
Decline of fever within 48hrs duration of fever
Total fever period
Chest X-ray finding
WBC, CRP
Key secondary outcomes
Bacteriological therapeutic efficacy response
The change of the mycoplsmaPCR amount of nasopharynx after antibiotic administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Treatment with azithromycin
Interventions/Control_2
Treatment with tosufloxacin
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
| 192 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients was suspected of Mycoplasma infection
Key exclusion criteria
side effect and allergic reaction
No consent
Refusal of taken a medicine
Patient with progressive or severe disease
Severe renal and hepatic dysfunction
Patient with allergic history to azithromycin or tosufloxacin
Patient judged of inappropriate by doctor
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Tanaka |
Organization
kawasaki medical college
Division name
Department of Pediatrics
Zip code
Address
577 Matsushima, Kurasiki city, Okayama
TEL
0864621111
takaaki51@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Tanaka |
Organization
Kawasaki medical college
Division name
Department of Pediatrics
Zip code
Address
577 Matsushima, Kurasiki city, Okayama
TEL
0864621111
Homepage URL
takaaki51@hotmail.com
Sponsor or person
Institute
Kawasaki medical college
Institute
Department
Personal name
Funding Source
Organization
Kawasaki medical college
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
non
Name of secondary funder(s)
non
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
あさき小児科（岡山県）、いなだ医院（岡山県）、茶屋町こどもクリニック（岡山）、うめもとこどもクリニック(三重県)、大倉クリニック（兵庫県）、おかだ小児クリニック（香川県）、岡藤小児科医院（兵庫県）、国立病院機構東佐賀病院（佐賀県）、川崎病院小児科（岡山県）、児島中央病院（岡山県）、落合小児病院（三重県）、かねはら小児科（山口県）、かねまつ小児科（岡山県）、青葉こどもクリニック（山口県）、倉敷中央病院小児科（岡山県）、佐賀県立病院好生館（佐賀県）、くわのキッズクリニック（福岡県）、こが小児科医院（福岡県）、古賀小児内科病院（佐賀県）、こむら小児科（福岡県）、佐久間小児科医院（福岡県）、塩月内科小児科医院（大分県）、しまだ小児科（熊本県）、倉敷リバーサイド病院小児科（岡山県）、杉村こどもクリニック（福岡県）、たけだ小児科（岡山県）、水島中央病院小児科（岡山県）、冨田医院（福岡県）、長井小児科医院（福岡県）、真備中央病院小児科（岡山県）、児島中央病院小児科（岡山県）、ながたこどもクリニック（広島県）、江の浦医院（福岡県）、嘉麻赤十字病院小児科（福岡県）、橋野こどもクリニック（佐賀県）、藤沢こどもクリニック（香川県）、羽島こども診療所（岡山県）、吉野こどもクリニック（福岡県）、倉敷成人病センター（岡山県）、ももたろうクリニック（岡山県）、やまぐち小児科（山口県）、やまだ小児科（佐賀県）、旭川旭川厚生病院（北海道）、国立病院機構三重病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Macrolide-resistant M.pneumoniae distributed in Japan(2008March~2013December).
The isolation of macrolide-resistant M.pneumoniae from ca 73%(686/939) of clinical specimens collected from pediatric patient in Japan : distribution :61% (69/113)in Kyusyu area, 67%(225/336) in Chugoku area, 93%(75/81) in Shikoku area, 78%(140/176) in Kinki area, 69%(43/62) in Hokkaido area, 83%(95/114) in Tokai area, 58%(21/36) in Kanto area.
Macrolide-resistant M.pneumoniae which was isolated from patient without treatment is 47% (N=156).
MR patients: WBC7621, CRP2.21
MS patients: WBC8332, CRP2
Macrolide-resistant M.pneumoniae strains have single point mutation in the 23SrRNA gene either on A2063G(97%) or on A2063T(2%).
Days of fever
The days of fever with administration of macrolide to patient infected with MR were significantly longer than those of infected with MS (mean of 3.74 days versus 1.23 day, P=0.0001).
We consider that the patients are infected with MR if the days of fever are two and more.
The duration of fever with administration of RKM to pateint infected Mycoplasma were shorter than cases of CAM and AZM.
The days of fever with administration of minocycline and tosufloxacin to patient infected with MR were significantry more effective than macrolide to patient (mean of 1.23days versus 1.57days versus 3.74days).
The quantitative PCR showed that the treatment with macrolide resulted in a mild decrease in amount of MR.
The quantitative PCR showed that the treatment with either tosufloxacin or minocycline resulted in a decrease in amount of MR.
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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 09 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004295
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