Prevention of tungiasis - associated morbitity in a resource-poor community in Madagascar
| ISRCTN | ISRCTN11415557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11415557 |
| Protocol serial number | N/A |
| Sponsor | Doctors for the Third World [Ärzte für die dritte Welt] (Germany) |
| Funder | Doctors for the Third World [Ärzte für die dritte Welt] (Germany) |
- Submission date
- 13/07/2011
- Registration date
- 28/09/2011
- Last edited
- 17/12/2020
- 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 a parasitic skin disease caused by the sand flea. It occurs in economically deprived communities such as in Madagascar. It is associated with considerable illness, such as chronic lymphoedema (swelling), ulcers, fissures, nail loss, difficulty in walking and gripping and infection. The only efficient measure against is surgical extraction with generally non sterile material causing further illness. The aim of this study is to test preventive measures to reduce tungiasis-related illness.
Who can participate?
Patients aged 5 and over with tungiasis
What does the study involve?
Participants are randomly allocated to one of three groups. In the first group Zanzarin (an insect repellent) is applied twice daily on the feet and ankles for 3 months, in the second group participants receive sport shoes, and the third group receive no treatment. The number of tungiasis lesions are counted every two weeks during the 3-month study. At the end of the study after 3 months all participants receive sport shoes, and if there are remaining tungiasis lesions these are extracted at the local health center, and local antibiotics and tetanus vaccinations are given.
What are the possible benefits and risks of participating?
Not provided at time of registration
When is the study starting and how long is it expected to run for?
August to October 2011
Where is the study run from?
Villages in the area of Andasibé in Moramanga district in Madagascar
Who is funding the study?
Doctors for the Third World (Ärzte für die dritte Welt) (Germany)
Who is the main contact?
Prof. Hermann Feldmeier
Contact information
Scientific
am Rain 7
Buchholz in Nordheide
21244
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Morbidity prevention of tunga penetrans in a resource-poor community in Madagascar: a randomized controlled trial |
| Study objectives | The regular application of Zanzarin®, a coconut oil-based plant repellent, protects against morbidity associated with Tunga penetrans. The trial will evaluate the effacacy Zanzarin® compared to the wearing of shoes. |
| Ethics approval(s) | Ethics Committee of the Health Ministry of Madagascar, 05/05/2011 |
| Health condition(s) or problem(s) studied | Tungiasis |
| Intervention | Three cohort groups: 1. Zanzarin® ( active ingredients: capric acid, cocos nucifera, citronellol) : topical application 5 ml twice daily on the feet and ankles for 3 months 2. Wearing sports shoes 3. Control group, no intervention |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Zanzarin® |
| Primary outcome measure(s) |
To assess the impact of the different interventions the following outcome measures will be compared every two weeks during three month. Lesion stage will be assessed according the Fortaleza Classification. |
| Key secondary outcome measure(s) |
To assess the impact of the different interventions the following outcome measures will be compared: |
| Completion date | 30/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 225 |
| Key inclusion criteria | 1. More than or equal to 10 tungiasis lesions 2. Aged more than or equal to 5 years 3. 4-5 days of permanence in the village per week 4. Permanence in the village during next 4 months 5. The participants or their legal guardian have signed the informed written consent |
| Key exclusion criteria | 1. Less than or equal to 10 tungiasis lesions 2. Aged less than 5 years 3. Less than 4-5 days of permanence in the village per week 4. Less than 4 months permanence in the village 5. The participants or their legal guardian have not signed the informed written consent |
| Date of first enrolment | 01/08/2011 |
| Date of final enrolment | 30/10/2011 |
Locations
Countries of recruitment
- Germany
- Madagascar
Study participating centre
21244
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | substudy results | 15/09/2017 | 17/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/12/2020: Publication reference added.
19/04/2017: Plain English summary added.
