UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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).
Title of the study (Brief title)	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	Shoji Kawachi
Organization	Teikyo University
Division name	the Asia International Institute of Infectious Disease Control (ADC)
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	Shoji Kawachi
Organization	Teikyo University
Division name	the Asia International Institute of Infectious Disease Control (ADC)
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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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