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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002236
Receipt No. 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

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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
Institute NEOCI (Nagasaki Evaluation Organization for Clinical Interventions)
Institute
Department

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
URL(English) https://upload.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


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