UMIN-CTR Clinical Trial

Public title

Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-

Acronym

Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-

Scientific Title

Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-

Scientific Title:Acronym

Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-

Region

Asia(except Japan)

Condition

Kala-azar (visceral leishmaniasis) and post-kala-azar dermal leishmaniasis

Classification by specialty

Medicine in general	Nephrology	Infectious disease
Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Kala-azar (visceral leishmaniasis) and post-kala-azar dermal leishmaniasis are prevalent in Bangladesh. However, the epidemiology of these diseases, especially in terms of diagnosis, treatment, and outcome, has not yet been fully elucidated. The aim of this study is therefore to improve understanding of these diseases by creating a database.

Basic objectives2

Others

Basic objectives -Others

Epidemiology (no experimental intervention)

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Short- and long-term patient outcomes (1 month to 3 years) by treatment plan, especially the onset of post-kala-azar dermal leishmaniasis

Key secondary outcomes

1.Details of patient background, history, subjective symptoms, and objective findings at the time of diagnosis
2.Assessing the diagnostic effectiveness of serum and urine biomarkers

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who visit the participating facilities and are diagnosed with kala-azar (visceral leishmaniasis) or post-kala-azar dermal leishmaniasis

Key exclusion criteria

Patients who refuse to participate in this observational study

Target sample size

1000

Name of lead principal investigator

1st name	Eisei
Middle name
Last name	Noiri

Organization

The University of Tokyo Hospital

Division name

Department of Hemodialysis and Apheresis

Zip code

113-0033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan

TEL

+81-3-3815-5411

Email

noiri-tky@umin.ac.jp

Name of contact person

1st name	Eisei
Middle name
Last name	Noiri

Organization

The University of Tokyo Hospital

Division name

Department of Hemodialysis and Apheresis

Zip code

113-0033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan

TEL

+81-3-3815-5411

Homepage URL

http://satreps-kalaazar.com/index.html

Email

noiri-tky@umin.ac.jp

Institute

Science and Technology Research Partnership for Sustainable Development (SATREPS)

Institute

Department

Personal name

Organization

Department of Hemodialysis and Apheresis, the University of Tokyo Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Suruya Kanta Kala-azar Research Center (SKKRC) in Bangladesh

Name of secondary funder(s)

None

Organization

The University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan

Tel

+81-3-3815-5411

Email

noiri-tky@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Suruya Kanta Kala-azar Research Center（SKKRC）in Bangladesh

Date of disclosure of the study information

2013

Year

08

Month

13

Day

URL releasing protocol

http://satreps-kalaazar.com/en/index.html

Publication of results

Published

URL related to results and publications

https://link.springer.com/book/10.1007/978-3-319-47101-3

Number of participants that the trial has enrolled

975

Results

Leishmaniasis is a zoonotic disease transmitted by sand flies. Visceral leishmaniasis, its most severe form, affects at least 300,000 people annually and is classified as an NTD. Our project began in 2007 and expanded into SATREPS in 2010, aiming to eliminate the disease by sharing practical Japanese diagnostic and field-survey techniques and strengthening the capacity of local researchers.
https://www.jica.go.jp/oda/project/1000330/

Results date posted

2026

Year

08

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Under the AMED SATREPS project entitled "Project for Establishment of a Diagnostic System and Vector Control Measures for Visceral Leishmaniasis," SKKRC was established as a Kala-azar CDC in Mymensingh, Bangladesh, with local support from JICA and in collaboration with icddr,b and Mymensingh Medical College. Based on geographic information on visceral leishmaniasis patients who visited SKKRC for treatment, areas with clusters of infection were identified in the outskirts of Mymensingh. Community-based screening was then conducted in these areas, and additional individuals who tested positive were identified and registered.
https://www.u-tokyo.ac.jp/focus/en/articles/t_163.html

Participant flow

The treatments were administered by physicians dispatched by the Ministry of Health of Bangladesh, and blood samples were similarly collected by nurses dispatched by the Ministry. Blood testing was performed using laboratory equipment that we installed at SKKRC. The treatments were provided free of charge according to treatment protocols prescribed by the Ministry of Health of Bangladesh. Patients' physical findings, blood biochemical data, and treatment protocols were recorded in the database. The results are presented in the outcome measures described below and are detailed in the aforementioned book.

Adverse events

No adverse events related to this study were reported.

Outcome measures

The outcomes of this study were extensive and detailed, as the project rapidly expanded in scope after the establishment of SKKRC as a research and clinical center. Its activities encompassed not only the treatment of patients in the surrounding communities and epidemiological investigations of infection, but also vector surveys and investigations of residential areas using the mid-atmosphere observation satellite "Ohzora." Accordingly, the study included a wide range of detailed outcome measures. The findings were compiled and published in Kala Azar in South Asia: Current Status and Sustainable Challenges (Springer, 2016). To date, the book has received more than 10,000 accesses from around the world and is one of the most widely read and highly regarded books in this field. The principal investigator, E. Noiri, served as an editor and also contributed to the book.
https://link.springer.com/book/10.1007/978-3-319-47101-3

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

03

Month

18

Day

Date of IRB

2011

Year

12

Month

20

Day

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patient Background Data
History
Subjective Symptoms
Objective Findings
Physical Examination
Laboratory and Physiological Tests
Treatment Plan
One-month follow-up
Six-month follow-up
one-year follow-up
Two-year follow-up
Three-year follow-up

Registered date

2013

Year

08

Month

08

Day

Last modified on

2026

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013374