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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026440
Receipt No. R000030003
Scientific Title Clinical trial to evaluate the effect of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia in Filipino children 2-5 years old ( a pilot study).
Date of disclosure of the study information 2017/03/08
Last modified on 2017/03/07

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Basic information
Public title Clinical trial to evaluate the effect of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia in Filipino children 2-5 years old ( a pilot study).
Acronym Study on the use of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia of children
Scientific Title Clinical trial to evaluate the effect of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia in Filipino children 2-5 years old ( a pilot study).
Scientific Title:Acronym Study on the use of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia of children
Region
Japan Asia(except Japan)

Condition
Condition severe and very severe community-acquired pneumonia
Classification by specialty
Pneumology Infectious disease Pediatrics
Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the clinical course of severe and very severe pneumonia and evaluate the effect of Leucomycin/Josamycin against community-acquired pneumonia in Filipino children 2-5 years of age.
To observe the clinical course of pneumonia and assess the efficacy of Josamycin in pneumonia of children.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Mortality
Duration of response to therapy
Duration of signs and symptoms of the disease
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
Interventions/Control_1 Josamycine 30 mg/kg BW/days for maximum 14 days.
1. Use dry syrup of Josamycin 10%.
(Josamy DS : Josamycin 10% dry syrup)
2. 10mg/kg BW x 3 times/day p.o. administration
3. Will be able to continue up to 14 days (2 weeks)
4. Patient's family member let the patient take it. If it is difficult to take as it is, dissolve in a small amount of water (less than 5 ml) to give.
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
2 years-old <=
Age-upper limit
5 years-old >=
Gender Male and Female
Key inclusion criteria Severe and very severe community-acquired pneumonia (based on WHO definition)

Patients who filfull all of the followings(1-6:should be included,7:if possible)
1.The patients seen at the UP-PGH. (Out-patient and Hospitalized patients)
2.Age:2-5 years old
3.Chest X ray abnormal shadow(consolidation, ground-glass opacity, or nodular shadow)
4.High fever(over 38 degree) on admission
5.Patients provide written informed consent prior to initiation of any study procedures.
6.Patients who or Legally Acceptable Representative (LAR) is able to understand and comply with planned study procedures.
7.PaO2/FiO2 ratio (P/F ratio) is lower than 300 mmHg in arterial blood gas analysis.
Key exclusion criteria Patients who fulfill any of the followings are excluded
1.Patients with severe renal dysfunction (creatinine clearance is lower than 10mL/min)
2. Patients whom the treating doctor deems, for any reason, to be ineligible.
3. Patients with underlying heart conditions i.e. congenital heart disease.
4. The patient's LAR wants to stop the study,even if after the study have started.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Kawachi
Organization Teikyo University
Division name the Asia International Institute of Infectious Disease Control (ADC)
Zip code
Address 2-11-1,Kaga Itabashi-ku, Tokyo
TEL 03-3964-1211
Email office-adc@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoji Kawachi
Organization Teikyo University
Division name the Asia International Institute of Infectious Disease Control (ADC)
Zip code
Address 2-11-1,Kaga Itabashi-ku, Tokyo
TEL 03-3964-1211
Homepage URL
Email office-adc@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor the Department of Science and Technology- Philippine Council for Health Research and Development (DOST-PCHRD)
the University of the Philippines-Philippine General Hospital (UP-PGH)
Name of secondary funder(s) The Department of Science and Technology, through the Philippine Council for Health Research and Development a government agency, Philippine

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 フィリピン大学‐フィリピン総合病院(マニラ、フィリピン)
the University of Philippines-Philippine General Hospital(Manila, Philippine )

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 08 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
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 15 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
2017 Year 03 Month 07 Day
Last modified on
2017 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030003

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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