UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027485
Receipt number 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 13:03:15

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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 or person

Institute

University of Miyazaki

Institute

Department

Personal name



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

Value
https://center6.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