UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005371
Receipt number R000006376
Scientific Title Efficiency of Oseltamivir (Tamiflu) with Azithromycin Sustained Release (Zithromac SR) for inflammation
Date of disclosure of the study information 2011/04/04
Last modified on 2011/07/22 09:47:32

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Basic information

Public title

Efficiency of Oseltamivir (Tamiflu) with Azithromycin Sustained Release (Zithromac SR) for inflammation

Acronym

Efficiency of Oseltamivir with AZM for influenza

Scientific Title

Efficiency of Oseltamivir (Tamiflu) with Azithromycin Sustained Release (Zithromac SR) for inflammation

Scientific Title:Acronym

Efficiency of Oseltamivir with AZM for influenza

Region

Japan


Condition

Condition

Influenza

Classification by specialty

Medicine in general Pneumology Infectious disease
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation for AZM with oseltamivir for influenza

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Inhibitory effects of inflammatory cytokines/chemokines, including HMGB-1 and PCT in sera of the patients

Key secondary outcomes

Fever, Symptoms, Complications, and Adverse effects


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oseltamivir alone

Interventions/Control_2

Oseltamivir plus Azithromycin Sustained Release

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who satisfied below 1-6:
1. Age:>=20
2. Agreement with documents
3. Fever>=38.0 degrees Celsius
4. >=2 items of ISS* which as moderate symptoms
5. Within 48hour after onset:
Onset time is defined as below
1) First time at increase of body temperature (>= 1 degrees Celsius as usual)
2) First time which the patient
aware >= 1 items of ISS*
6. Positive for Rapid Antigen Test kit
*ISS=Influenza Symptoms Severity

Key exclusion criteria

1. Hypersensitive with the examined drugs
2. Using contraindicated drugs with the examined drugs
3. Inappropriate judged by doctors
Ex. Obvious bacterial superinfection
4. Using long and low dose Macrolides

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshifumi Imamura

Organization

Nagasaki University Hospital

Division name

Second Department of Internal Medicine

Zip code


Address

1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.

TEL

095-819-7273

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Nagasaki evaluation organization for clinical interventions

Division name

office

Zip code


Address


TEL


Homepage URL


Email

shinkin@peath.co.jp


Sponsor or person

Institute

Nagasaki evaluation organization for clinical interventions

Institute

Department

Personal name



Funding Source

Organization

Nagasaki evaluation organization for clinical interventions

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

長崎大学病院(長崎県)
日本赤十字社長崎原爆諌早病院(長崎県)
日本赤十字社長崎原爆病院(長崎県)
北松中央病院(長崎県)
佐世保市立総合病院(長崎県)
国立病院機構 嬉野医療センター(佐賀県)
医療法人 光晴会病院(長崎県)
健康保険諫早総合病院(長崎県)
長崎市立市民病院(長崎県)
おにつか内科・消化器科(長崎県)
医療法人 はやしだ内科(長崎県)
ともなが内科クリニック(長崎県)
入船クリニック(長崎県)
かわむら内科(長崎県)


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 04 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

Completed

Date of protocol fixation

2010 Year 10 Month 29 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2011 Year 02 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2011 Year 04 Month 01 Day

Date analysis concluded

2011 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 04 Month 04 Day

Last modified on

2011 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006376


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name