UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044320
Receipt number R000050621
Scientific Title An existing and experimental treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Homa Bay, Kenya
Date of disclosure of the study information 2021/05/28
Last modified on 2023/06/19 03:57:43

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Basic information

Public title

A clinical trial with two treatments of tungiasis in Homa Bay, Kenya

Acronym

A clinical trial with two treatments of tungiasis in Kenya

Scientific Title

An existing and experimental treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Homa Bay, Kenya

Scientific Title:Acronym

An existing treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Kenya

Region

Africa


Condition

Condition

Tungiasis

Classification by specialty

Dermatology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the most acceptable treatment for local treatment in children with tungiasis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

A difference in cure rate (embedded fleas' viability) on day 12.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

dimeticone (NYDA) for the first day

Interventions/Control_2

5% sodium carbonate solution for the first day

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

3 years-old <=

Age-upper limit

14 years-old >=

Gender

Male and Female

Key inclusion criteria

-Children who have been infected by tungiasis in Homa Bay, Kenya
-Children who provide written consent to participate in the study (parental consent will also be required)
-Children who have one to five embedded sand flea per foot

Key exclusion criteria

-Children with secondary bacterial infection based on the established rapid diagnostic method
-Children infested with massive fleas (more than 10 fleas)
-Children / Caregivers declined to participate

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kana
Middle name
Last name Suzuki

Organization

Nagasaki University

Division name

School of Tropical Medicine and Global Health

Zip code

852-8523

Address

1-12-4 Sakamoto, Nagasaki

TEL

81958197583

Email

ksuzuki@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Kana
Middle name
Last name Suzuki

Organization

Nagasaki University

Division name

School of Tropical Medicine and Global Health

Zip code

852-8523

Address

1-12-4 Sakamoto, Nagasaki

TEL

81958197583

Homepage URL


Email

ksuzuki@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Not applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

TMGH ethics review board, Nagasaki University

Address

1-12-4, Sakamoto, Nagasaki

Tel

81958197583

Email

tmgh_jimu@ml.nagasaki-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

2021 Year 05 Month 28 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

Open public recruiting

Date of protocol fixation

2021 Year 05 Month 25 Day

Date of IRB

2022 Year 12 Month 07 Day

Anticipated trial start date

2023 Year 01 Month 27 Day

Last follow-up date

2023 Year 02 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Data collection for a pilot study is finished.
About the adverse event, we have informed the Kenyan ethics committee (KEMRI-SERU) of the following.
Five participants got over 38 degree fever during the monitoring period, and one had with cough. All got a consultation with a medical doctor immediately. The medical doctor said there was no relation to the study, and one tested malaria positive. All were given the medication, and the following day, the fever was gone and other events didn't occur.
Next, we will consider whether to move on to the main research after analyzing the results.


Management information

Registered date

2021 Year 05 Month 25 Day

Last modified on

2023 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050621


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name