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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027485
Receipt No. R000030383
Scientific Title Efficacy and safety of injectable quinine for the treatment of malaria in Japan
Date of disclosure of the study information 2017/05/25
Last modified on 2019/11/25

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Basic information
Public title Efficacy and safety of injectable quinine for the treatment of malaria in Japan
Acronym Efficacy and safety of injectable quinine for the treatment of malaria in Japan
Scientific Title Efficacy and safety of injectable quinine for the treatment of malaria in Japan
Scientific Title:Acronym Efficacy and safety of injectable quinine for the treatment of malaria in Japan
Region
Japan

Condition
Condition malaria
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To treat severe malaria patients and malaria patients who cannot take oral anti-malaria drugs with injectable quinine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cure rate
Key secondary outcomes 1) time required for fever disappearance
2) parasite clearance time
3) recurrence after 28 days of treatment

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 Administer injectable quinine for the treatment of malaria (8.3 mg base/kgBW, 16.6 mg for loading)in 500 mL of 5% glucose or physiological saline, for upto 7 days.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Severe malaria patients or malaria patients who cannot take oral anti-malaria drugs, who agree to join the study.
Key exclusion criteria 1) Patients who are allergic to injectable quinine or related compounds
2) Patients who do not agree to give written informed consent
3) Patients principal who investigator considers inappropriate
Target sample size 33

Research contact person
Name of lead principal investigator
1st name Maruyama
Middle name
Last name Haruhiko
Organization University of Miyazaki
Division name Faculty of Medicine
Zip code 889-1692
Address 5200 Kihara, Kiyotake-Cho, Miyazaki City, Miyazaki, Japan
TEL 0985-85-0990
Email hikomaru@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Mizoguchi
Middle name
Last name Ayami
Organization University of Miyazaki
Division name Faculty of Medicine
Zip code 889-1692
Address 5200 Kihara, Kiyotake-Cho, Miyazaki City, Miyazaki, Japan
TEL 0985-85-0990
Homepage URL
Email ayami_mizoguchi@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hospital of University of Miyazaki Clinical Research Support Center
Address KIhara 5200, Kiyotake-cho, Miyazaki, Miyazaki 889-1692
Tel 0985-85-9403
Email rinken@med.miyazaki-u.ac.jp

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
2017 Year 05 Month 25 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
2017 Year 04 Month 05 Day
Date of IRB
2017 Year 06 Month 16 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 25 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030383

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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