Controlling Tungiasis in an Impoverished Community
| ISRCTN | ISRCTN27670575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27670575 |
| Secondary identifying numbers | 195/02 |
- Submission date
- 16/07/2008
- Registration date
- 12/09/2008
- Last edited
- 13/11/2008
- 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
Not provided at time of registration
Contact information
Prof Hermann Feldmeier
Scientific
Scientific
Institute for Microbiology and Hygiene
Charite - University Medicine Berlin
Campus Benjamin Franklin
Hindenburgdamm 27
Berlin
12203
Germany
Study information
| Study design | Non-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| Scientific title | Controlling tungiasis in an impoverished community: an intervention study |
| Study acronym | CTIC |
| Study objectives | The implementation of various control measures will result in a drop of prevalence and intensity of infestation of tungiasis. |
| Ethics approval(s) | Ethical Review Board of the Federal University of Ceará. Date of approval: 25/10/2002 (ref: 195/02) |
| Health condition(s) or problem(s) studied | Tungiasis (Tunga penetrans [sand flea] infestation) |
| Intervention | One village served as the intervention village and the other served as the control village. Target number of recruitment: 597 individuals in the intervention village and 234 individuals in the control village (total 831). The actual number of people living in the villages was 630 for the intervention village and 281 for the control village. Intervention village: From November 2002 through January 2003, from all infested individuals, embedded sand fleas were extracted every two to three weeks by experienced health care professionals under sterile conditions. The remaining sore was treated with an antibiotic ointment. During the same period all cats and dogs were treated with trichlorphone 97% in oily solution (Neguvon®, Bayer do Brasil, Brazil) or neck collars impregnated with propoxur and flumethrin (Kiltix®, Bayer Bayer do Brasil, Brazil). In February 2003, deltamethrin was used for focal premise treatment. Focal spraying was performed by trained personnel of the Health Secretariat of Cascavel Municipality. The insecticide was sprayed on the ground next to the houses targeting areas in which off-host development of T. penetrans was suspected to occur, such as preferred whereabouts of dogs and cats, and shady places under trees, or inside houses in the case of a sandy floor. Focal premise treatment using insecticides was repeated twice during a period of six weeks. No intervention took place in the control village. |
| Intervention type | Other |
| Primary outcome measure | Proportion of individuals infested with Tunga penetrans (Prevalence of tungiasis), measured 10 times during the 12 months study period in equal intervals. Reduction of prevalence was measured through comparison with the baseline level. |
| Secondary outcome measures | Number of embedded sand fleas per infested individual, measured 10 times during the 12 months study period in equal intervals. This intensity of infestation was measured in terms of categories and total number, both compared to baseline levels. |
| Overall study start date | 14/11/2002 |
| Completion date | 20/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 831 |
| Key inclusion criteria | 1. Inhabitants of all age groups, both males and females, were eligible for the study, provided they had spent at least four days per week in the village during the last three months 2. Informed written consent obtained from study participant and carers |
| Key exclusion criteria | 1. Absence from the study area for more than 4 days per week 2. Unwillingness to participate |
| Date of first enrolment | 14/11/2002 |
| Date of final enrolment | 20/11/2003 |
Locations
Countries of recruitment
- Brazil
- Germany
Study participating centre
Institute for Microbiology and Hygiene
Berlin
12203
Germany
12203
Germany
Sponsor information
Mandacaru Foundation (Brazil)
Charity
Charity
Rua José Vilar de Andrade 257
Fortaleza
CE 60833-830
Brazil
| Website | http://www.mandacaru-foundation.org |
|---|---|
"ROR" |
https://ror.org/05h876969 |
Funders
Funder type
Charity
Mandacaru Foundation (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/11/2008 | Yes | No |
