UMIN-CTR Clinical Trial

Public title

Evaluation of optimal infusion volume with liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis

Acronym

Evaluation of optimal infusion volume with liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis

Scientific Title

Evaluation of optimal infusion volume with liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis

Scientific Title:Acronym

Evaluation of optimal infusion volume with liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis

Region

Japan

Condition

Chronic pulmonary aspergillosis

Classification by specialty

Pneumology

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of renal dysfunction by undertaking infusion volume in liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison of the renal dysfunction between hydration group and non-hydration group

Key secondary outcomes

The change of various electrolytes
The change of renal dysfunctional marker
The change of body weight

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

L-AMB is given intravenously at 3.0mg/kg every 24h for 2 weeks.

Interventions/Control_2

L-AMB is given intravenously at 3.0mg/kg every 24h for 2 weeks after undertaking Sordem 3A 500ml.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Chronic respiratory symptom or systemic symptom; i.e. the existence of at least one of the symptoms of fever, weight loss, sputum, cough, hemoptysis, fatigue, and dyspnea
(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 inflammation markers such as white blood cell (WBC) counts, value of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).

Key exclusion criteria

1.Patients who received L-AMB within one month before the time of enrollment
2.Patients with intravenous leukocyte infusion
3.Pregnant patients
4.Patients with renal insufficiency(CKD morethan 3b)
5.Patients anticipating being postrenal failure using abdominal ultracound
6.Patients with cardiac disorders(EF less than 50% or E/A more than 1 using echocardiography)
7.Patients deemed ineligible by the attending physicians for various reasons.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Toshinori Kawanami

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Respiratory Medicine

Zip code

Address

1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka, 807-8555, Japan

TEL

093-691-7453

Email

namihei@med.uoeh-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshinori Kawanami

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Respiratory Medicine

Zip code

Address

1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka, 807-8555, Japan

TEL

093-691-7453

Homepage URL

Email

namihei@med.uoeh-u.ac.jp

Institute

Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan

Institute

Department

Personal name

Organization

Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan

Organization

Division

Category of Funding Organization

Self funding

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

2013

Year

12

Month

25

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

2013

Year

10

Month

16

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

25

Day

Last modified on

2013

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014823