UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003450 |
|---|---|
| Receipt number | R000004143 |
| Scientific Title | Studies on the additive effects of macrolide antibiotics in the treatment in avian and swine influenza virus infected-patients treated with anti-influenza drugs |
| Date of disclosure of the study information | 2010/04/05 |
| Last modified on | 2014/10/05 09:14:17 |
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Basic information
Public title
Studies on the additive effects of macrolide antibiotics in the treatment in avian and swine influenza virus infected-patients treated with anti-influenza drugs
Acronym
Studies on the additive effects of macrolide antibiotics in the treatment in avian and swine influenza virus infected-patients treated with anti-influenza drugs
Scientific Title
Studies on the additive effects of macrolide antibiotics in the treatment in avian and swine influenza virus infected-patients treated with anti-influenza drugs
Scientific Title:Acronym
Studies on the additive effects of macrolide antibiotics in the treatment in avian and swine influenza virus infected-patients treated with anti-influenza drugs
Region
| Japan |
Condition
Condition
Avian and swine influenza virus infection
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to study the additive effects of macrolide antibiotics in the treatment in avian and swine influenza virus infected-patients treated with anti-influenza drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence of nasal discharge and sputum after 5-days of treatment.
Key secondary outcomes
1) The presence of cough 5 days after the treatment.
2) Duration or time of fever 38 degree centigrade or more.
3) Presence of complication with pneumonia.
4) Serum concentrations of inflammatory cytokines (interleukin-1, interleukin-6, TNF-alpha, TGF-beta) after 5-days of treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with neuraminidase inhibitors plus macrolide antibiotics
Interventions/Control_2
Treatment with neuraminidase inhibitors without macrolide antibiotics
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed as type A influenza infection.
2.Patients 16 years old and more, and high school students less than 16 years old.
3.Patients who understand the purpose of this study, and sign agreement forms.
Key exclusion criteria
1. Patients with hypersensitivity to macrolide antibiotics.
2.Patients being treated with agents as follows: pimozide, and agents including ergotamine.
3.Patients judged inappropriate for the study by physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mutsuo Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7184
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsuo Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7184
Homepage URL
myamaya@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University Graduate School of Medicine
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
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
東北大学病院（宮城県）、栗原中央病院（宮城県）、岩手県立磐井病院（岩手県）、岩切病院（宮城県）、東京慈恵会医科大学附属病院（東京都）、済世会宇都宮病院（栃木県）、ひがし内科クリニック（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2010 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 05 | Day |
Last modified on
| 2014 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004143
