Control of sand fleas in the soil using insect growth regulators
| ISRCTN | ISRCTN16207849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16207849 |
| Secondary identifying numbers | KEMRI-SERU-NON-KEMRI 4383 |
- Submission date
- 12/05/2025
- Registration date
- 23/06/2025
- Last edited
- 23/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Tungiasis is the disease caused by the sand fleas, often referred to as "jiggers" in Kenya. Jiggers burrow into the skin of people's feet, causing much pain and itching. When the jiggers produce eggs, they drop to the floor as a person walks or rests. The eggs then hatch into a larva and develop into an adult in the soil. The adult female then seeks a person and burrows into the foot. The best method to control the jiggers is to prevent people from getting infected. Flea control products in animal medicine often include an ingredient that prevents the insect to grow and develop, which is called an insect growth regulator. Such an ingredient is, for example, pyriproxyfen. This study aims to test the effectiveness of pyriproxyfen as a potential control tool.
Who can participate?
The study enrolled households with natural earthen floors and at least 2 infected family members in Kwale County.
What does the study involve?
Households were randomly allocated to three groups, each with 34 houses: 1) water-based emulsified pyriproxyfen solution, 2) water only, and 3) no treatment at all. Treatment of floors was done every 5 days for groups 1 and 2. Group 3 were only recruited at the end of the trial. Soil samples were collected from all enrolled houses (group 1-3) at day 29 after the start of the trial. All participants were examined by trained community health volunteers, and treatment was provided as per county guidelines.
What are the possible benefits and risks of participating?
The benefits of this study are that all infected individuals during the study are referred to the nearest health facility for treatment. The risks of participating are that it would have been time-consuming.
Where is the study run from?
International Centre for Insect Physiology and Ecology (icipe), Muhaka field station in Kwale County, Kenya
When is the study starting and how long is it expected to run?
October 2022 to December 2022
Who is funding the study?
The German Research Foundation
Who is the main contact?
Dr. Ulrike Fillinger of the International Centre for Insect Physiology and Ecology, Nairobi, Kenya; ufillinger@gmail.com
Contact information
Public, Principal Investigator
International Centre for Insect Physiology and Ecology (icipe)
Duduville Campus
Thika Road
Nairobi
00100
Kenya
 ORCID ID |
0000-0002-4037-431X |
|---|---|
| Phone | +254791845259 |
| ufillinger@gmail.com |
Scientific
International Centre for Insect Physiology and Ecology (icipe)
Duduville Campus
Thika Road
Nairobi
00100
Kenya
| ORCID ID |
0000-0002-0045-5588 |
|---|---|
| Phone | +254741769030 |
| amatharu@icipe.org |
Study information
| Study design | Household-based single-center randomized controlled open-label intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention, Efficacy |
| Participant information sheet | 47321_PIS.pdf |
| Scientific title | Testing insect-growth regulators to control off-host stages of Tunga penetrans |
| Study objectives | The insect growth regulator, pyriproxyfen, will inhibit the development of Tunga penetrans eggs, larvae and pupae in the soil of unsealed earthen house floors, reducing the population of the parasitic adult females and the prevalence of tungiasis. |
| Ethics approval(s) |
Approved 02/03/2022, Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) (P.O Box 54840, Nairobi, 00200, Kenya; +254 2722541; director@kemri.org), ref: NON-KEMRI 4383 |
| Health condition(s) or problem(s) studied | Tungiasis |
| Intervention | A household randomized controlled study with three arms: 1. Water-based emulsified pyriproxyfen solution (0.06 ppm) 2. Water only 3. No treatment at all The households enrolled on arms 1 and 2 had their house floors sprayed once a week for 4 weeks. For all three study arms, household members were examined for embedded fleas at baseline and week 5, and soil samples were collected from the floors of sleeping rooms of households in all three study arms at week 5. |
| Intervention type | Other |
| Primary outcome measure | Proportion of households containing off-host stages of the sand flea Tunga penetrans measured using count data of the flea larvae extracted in the laboratory at baseline and week 5 |
| Secondary outcome measures | 1. The flea abundance (number of larvae per unit of soil) measured using count data of the flea larvae extracted in the laboratory at baseline and week 5 2. Any potential change of tungiasis infection in household members measured using a comparison of standard rapid assessments of feet at baseline and end-line |
| Overall study start date | 29/11/2021 |
| Completion date | 09/02/2023 |
Eligibility
| Participant type(s) | Resident |
|---|---|
| Age group | Mixed |
| Lower age limit | 6 Months |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 105 households |
| Total final enrolment | 102 |
| Key inclusion criteria | 1. Households with a natural earthen floor 2. Total floor area of households less than 72 square meters. A maximum size limit was set to limit the amount of product that needed to be prepared 3. Households with at least two members with more than 5 embedded fleas 4. The head of the household provided signed consent to participate |
| Key exclusion criteria | Households that were in very poor condition and considered likely to collapse within the timeframe of the study |
| Date of first enrolment | 24/10/2022 |
| Date of final enrolment | 15/12/2022 |
Locations
Countries of recruitment
- Kenya
Study participating centres
80400
Kenya
Kenya
Kenya
Sponsor information
Research organisation
icipe
Duduville Campus
Thika Road
Kasarani
Nairobi
00100
Kenya
| Phone | +254-20-8632000 |
|---|---|
| icipe@icipe.org | |
| Website | https://www.icipe.org/ |
"ROR" |
https://ror.org/03qegss47 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 28/05/2025 | No | Yes |
Additional files
Editorial Notes
12/05/2025: Study's existence confirmed by the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU).
