Prevention of tungiasis - associated morbitity in a resource-poor community in Madagascar

ISRCTN ISRCTN11415557
DOI https://doi.org/10.1186/ISRCTN11415557
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Hermann Feldmeier
Scientific

am Rain 7
Buchholz in Nordheide
21244
Germany

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleMorbidity prevention of tunga penetrans in a resource-poor community in Madagascar: a randomized controlled trial
Study objectivesThe 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) studiedTungiasis
InterventionThree 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Zanzarin®
Primary outcome measureTo 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.
1. Total number of lesions located at the feet
2. Number of viable lesions (stage 1-3)
3. Number of non-viable lesions (stage 4)
4. Ratio of viable lesions (stage 1 to 3) divided by total number of lesions
5. Ratio of non-viable lesions (stage 4) divided by total number of lesions
6. Percentage of participants without viable lesions at the end of the study
7. Severity score for acute and chronic tungiasis-associated morbidity

To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.
Secondary outcome measuresTo assess the impact of the different interventions the following outcome measures will be compared:
1. Percentage of participants without viable lesions at the end of the study
2. Modified severity score for acute and chronic tungiasis-associated morbidity

To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.
Overall study start date01/08/2011
Completion date30/10/2011

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants225
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2011
Date of final enrolment30/10/2011

Locations

Countries of recruitment

  • Germany
  • Madagascar

Study participating centre

am Rain 7
Buchholz in Nordheide
21244
Germany

Sponsor information

Doctors for the Third World [Ärzte für die dritte Welt] (Germany)
Charity

Offenbacher Landstraße 224
60599 Frankfurt am Main
Frankfurt am Main
60599
Germany

Website http://www.aerzte3welt.de/
ROR logo "ROR" https://ror.org/001m0em47

Funders

Funder type

Charity

Doctors for the Third World [Ärzte für die dritte Welt] (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

17/12/2020: Publication reference added.
19/04/2017: Plain English summary added.