UMIN-CTR Clinical Trial

Public title

Prospective study for clinical effectiveness and safety of TAZ/PIPC for the prevention of infectious complication of high risk lung cancer surgery

Acronym

Antimicrobial prophylaxis with TAZ/PIPC for the infectious complication of high risk lung cancer surgery

Scientific Title

Prospective study for clinical effectiveness and safety of TAZ/PIPC for the prevention of infectious complication of high risk lung cancer surgery

Scientific Title:Acronym

Antimicrobial prophylaxis with TAZ/PIPC for the infectious complication of high risk lung cancer surgery

Region

Japan

Condition

Malignant lung tumor

Classification by specialty

Infectious disease

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this prospective study is to elucidate efficacy and safety of TAZ/PIPC utilizing the CDC method for high risk lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Rate of the post-operative infectious complications

Key secondary outcomes

1 Safety
2 Rate of potentially or verified drug-resistant pathogen in the sputum collected by the post-operative bronchofiberscope

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

TAZ/PIPC 4.5g is administered twice, 30 minute before the operation and about 3 hours later. Unless infectious complication is observed, the antimicrobial prophylaxis is performed on the operation day only, according to the CDC guideline.

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who satisfy the criteria of 1), 2), 3), 4), and at least one of the 5) are eligible for this study.

1)Patient who was diagnosed as lung cancer pathologically.
2)The projected operation is more than segmentectomy.
3)Performance Status (ECOG scale): 0 or 1
4)Noutrophilic leukocyte count >1500/mm3
Platelet count > 75,000/mm3
Hemoglobin = or > 9.0g/dl
AST(GOT)/ALT(GPT) = or <100 IU/L
Total bilirubin = or < 2.0mg/dl
PaO2 = or > 60Torr
Creatinine clearance = or > 50ml/min [with Cockcroft-Gault method]
or serum creatin level: within normal limits
5)According to "Health-Care Associated Pneumonia (HCAP)" criteria,
*Patients who were hospitalized for more than two days for the past 90 days
*Patients who were admitted to nursing homes, care/rehabilitation facilities or health/care facilities for recuperation (for more than 48 hours)
*Patients who receive hemodialysis therapy for renal failure
*Patients whoes family was proven to be colonized by multidrugresistant bacteria
*Patients who suffer from diabetes mellitus or immunodeficiency
*Patients who receive steroids or other immunosuppressant

Key exclusion criteria

1)Patients with the medical history of hypersensitivity to penicillin
2)Patients who suffer from active infectious disease or were proven to be colonized by MRSA
3)Patients who have other malignant tumor

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Ichiro Yoshino

Organization

Graduate School of Medicine, Chiba University

Division name

Department of General Thoracic Surgery

Zip code

Address

1-8-1 Inohana, Chiba-shi, Chiba, Japan 271-8511

TEL

+81-43-222-7171

Email

Name of contact person

1st name
Middle name
Last name	Teruaki Mizobuchi

Organization

Graduate School of Medicine, Chiba University

Division name

Department of General Thoracic Surgery

Zip code

Address

1-8-1 Inohana, Chiba-shi, Chiba, Japan 271-8511

TEL

+81-43-222-7171

Homepage URL

Email

tmizobuchi@faculty.chiba-u.jp

Institute

Department of General Thoracic Surgery, Graduate School of Medicine, Chiba University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

04

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2010

Year

03

Month

29

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

25

Day

Last modified on

2010

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004288