UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026440 |
|---|---|
| Receipt number | 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 14:53:07 |
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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
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
office-adc@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030003
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
