UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002236
Receipt number R000002729
Scientific Title Intravenous liposomal amphotericin B versus intravenous voriconazole for chronic pulmonary aspergillosis: a multicenter, open-labeled trial in Japan
Date of disclosure of the study information 2009/07/22
Last modified on 2012/11/13 13:48:30

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Basic information

Public title

Intravenous liposomal amphotericin B versus intravenous voriconazole for chronic pulmonary aspergillosis: a multicenter, open-labeled trial in Japan

Acronym

Comparison study between L-AMB and VRCZ for CPA

Scientific Title

Intravenous liposomal amphotericin B versus intravenous voriconazole for chronic pulmonary aspergillosis: a multicenter, open-labeled trial in Japan

Scientific Title:Acronym

Comparison study between L-AMB and VRCZ for CPA

Region

Japan


Condition

Condition

Chronic pulmonary aspergillosis

Classification by specialty

Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of efficacy of intravenous L-AMB and VRCZ against chronic pulmonary aspergillosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement of clinical symptoms and radiological findings in chest X-ray and CT at the two weeks after the initiation of drugs and the end of the treatment.

Key secondary outcomes

Improvement of inflamatory markers and mycological findings at the two weeks after the initiation of the drugs and the end of the treatment.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of antifungal drugs (liposomalamphotericin B)

Interventions/Control_2

Administration of antifungal drug (voriconazole)

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

CPA patients fulfilled with following conditions;
#1. Diagnosis criteria;
(1) existing al least one of symptom complex consisting of fever, weight loss, sputum, cough, hemoptysis, fatigue and shortness of breath. (2) New infiltrates or cavity formation or expansion of pre-existing cavities with or without peri-cavitary infiltrates and adjacent pleural thickening in last six months.
(3) at least one positive result of serologic tests including Aspergillus antigen test, antibody test and/or any positive evidences if existence of Aspergillus species by molecular diagnosis, culture positive and pathological findings.
(4) positive findings of at least one of the inflamation markers such as white blood cell (WBC) counts, value of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
(5) non-improvement of symptoms to at least 3 days-administration of wide-broad intravenous antibiotics (e.g. carbapenems, wide-broad cephems and penicillins, and quinolones).

#2. Patients who are given informed consents.

#3. Patients who are at least 20 years or older.

#4. Gender: male and female

#5. Patients are hospitalized.

Key exclusion criteria

The following patients are excluded from the study.
#1. Patients who are going to be excluded due to the difficulty of determine efficacy.
(1) patients received amphotericin B (AMPH-B), liposomal amphotericin B (L-AMB) or voriconazole (VRCZ) within a month at the time of the diagnosis of CPA,
(2) patients received other antifungal drugs such as itraconazole, flucytosine, miconazole, fluconazole, nystatin or micafungin and have already started to being improved or with unknown medical course.
(3) patients who are diagnosed other than CPA.

#2. Patients who are going to be excluded due to the safety issues.
(1) patients who fulfilled the contraindication of AMPH-B, L-AMB and VRCZ.
(2) patients with liver, kidney and heart failure (more than Grade II in CTCAEv3.0).
(3) pregnant or breast feeding patients, and patients who are willing to have baby.

#3. Patients whom are considered to be excluded by the attending physicians with various reasons.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Kohno

Organization

Nagasaki University

Division name

Second Department of Internal Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN

TEL

095-819-7273

Email



Public contact

Name of contact person

1st name
Middle name
Last name Koichi Izumikawa

Organization

Nagasaki University

Division name

Second Department of Internal Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN

TEL

095-819-7276

Homepage URL


Email

koizumik@nagasaki-u.ac.jp


Sponsor or person

Institute

NEOCI (Nagasaki Evaluation Organization for Clinical Interventions)

Institute

Department

Personal name



Funding Source

Organization

NEOCI (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

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

2009 Year 06 Month 12 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry

2012 Year 05 Month 01 Day

Date trial data considered complete

2012 Year 07 Month 01 Day

Date analysis concluded

2012 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 07 Month 22 Day

Last modified on

2012 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name