UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002235
Receipt number R000002653
Scientific Title Inspection for the management guidelines of chronic respiratory infection in adults
Date of disclosure of the study information 2009/07/22
Last modified on 2011/07/22 09:43:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Inspection for the management guidelines of chronic respiratory infection in adults

Acronym

Inspectional study of Respiratory tract infection (Pulmonary Disease)

Scientific Title

Inspection for the management guidelines of chronic respiratory infection in adults

Scientific Title:Acronym

Inspectional study of Respiratory tract infection (Pulmonary Disease)

Region

Japan


Condition

Condition

Secondary infections of Chronic respiratory illness.

Classification by specialty

Medicine in general Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To not only survey for actual usage for secondary infection of chronic respiratory illness, including acute exacerbations of chronic bronchitis, bronchial asthma+infection, emphysema+infection, pneumonicosis+infection, old tuberculosis+infection, interstitial pnemonitis+infection, but also evaluation of efficiency and safety of antibiotics.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Efficacy and safety.

Key secondary outcomes

Antimicrobial efficacy


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Adult patients (<=20years)
Mild to moderate severity patients
At the time of antibiotics
administration, the patients who included following criteria: either fever 37.0 degrees Celsius, purulent sputum, WBC>8000/mm3, or CRP 0.7mg/dL.
The patients who understand the purpose of this study and side effects of drugs, and who declare their (including family) own will to participate this study orally or by documents (The doctors have to get the patients' agreements under facilities rules before entry to study. In case, certificates of patients' agreements will be necessary).

Key exclusion criteria

Patients whose diseases have taboo against the used antibiotics(See attached files).

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Kohno

Organization

Nagasaki University

Division name

School of Medicine

Zip code


Address

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

TEL

095-819-7418

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masafumi Seki

Organization

Nagasaki University

Division name

School of Medicine

Zip code


Address

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

TEL

095-819-7273

Homepage URL


Email

seki@nagasaki-u.ac.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

Non profit foundation

Nationality of Funding Organization

Japan


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

2009 Year 07 Month 22 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

Completed

Date of protocol fixation

2008 Year 04 Month 12 Day

Date of IRB


Anticipated trial start date

2008 Year 10 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry

2010 Year 06 Month 01 Day

Date trial data considered complete

2011 Year 04 Month 01 Day

Date analysis concluded

2011 Year 06 Month 01 Day


Other

Other related information

Prospective study
Outcome variable:
Efficiency and safety.


Management information

Registered date

2009 Year 07 Month 22 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=R000002653


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name