UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002893
Receipt number R000003528
Scientific Title Inhalation of tobramycin for the patients with persistent respiratory infection by Psudomonas aeruginosa
Date of disclosure of the study information 2009/12/14
Last modified on 2009/12/14 16:25:30

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Basic information

Public title

Inhalation of tobramycin for the patients with persistent respiratory infection by Psudomonas aeruginosa

Acronym

Inhalation of tobramycin

Scientific Title

Inhalation of tobramycin for the patients with persistent respiratory infection by Psudomonas aeruginosa

Scientific Title:Acronym

Inhalation of tobramycin

Region

Japan


Condition

Condition

Persistent respiratory infection by Pseudomonas aeruginosa

Classification by specialty

Pneumology Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Treatment for the patients with persistent respiratory infection by Pseudomonas aeruginosa

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Appearance and amount of airway secretions, culture of airway secretions, body temperature, white blood cell count, titer of CRP, PaO2/FiO2 ratio, and chest radiography

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Patients with persistent respiratory infection by Pseudomonas aeruginosa that are difficult to be cured with intravenous antibiotics are administered inhaled tobramycin with nebulizer.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases with persistent respiratory infection by Pseudomonas aeruginosa that are difficult to be cured with intravenous antibiotics.

Key exclusion criteria

Cases with severe respiratory failure that require high density oxygen inhalation.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Kinoshita

Organization

Kumamoto university hospital

Division name

Emergency and critical care medicine

Zip code


Address

1-1-1 Honjo, Kumamoto, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kumamoto university hospital

Division name

Emergency and critical care medicine

Zip code


Address


TEL

096-373-7031

Homepage URL


Email



Sponsor or person

Institute

Kumamoto university hospital

Institute

Department

Personal name



Funding Source

Organization

Emergency and critical care medicine, Kumamoto university 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

2009 Year 12 Month 14 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

Preinitiation

Date of protocol fixation

2009 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2009 Year 12 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

2009 Year 12 Month 14 Day

Last modified on

2009 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name