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ISRCTN
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ISRCTN27670575
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DOI
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10.1186/ISRCTN27670575
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Controlling Tungiasis in an Impoverished Community
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Scientific title
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Controlling tungiasis in an impoverished community: an intervention study
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Acronym
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CTIC
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Serial number at source
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195/02
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Study hypothesis
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The implementation of various control measures will result in a drop of prevalence and intensity of infestation of tungiasis.
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Lay summary
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Ethics approval
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Ethical Review Board of the Federal University of Ceará. Date of approval: 25/10/2002 (ref: 195/02)
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Study design
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Non-randomised controlled trial
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Tungiasis (Tunga penetrans [sand flea] infestation)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Absence from the study area for more than 4 days per week
2. Unwillingness to participate
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Anticipated start date
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14/11/2002
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Anticipated end date
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20/11/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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831
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Mandacaru Foundation (Brazil)
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/pubmed/18941513
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Contact name
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Prof
Hermann
Feldmeier
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Address
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Institute for Microbiology and Hygiene
Charite - University Medicine Berlin
Campus Benjamin Franklin
Hindenburgdamm 27
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City/town
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Berlin
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Zip/Postcode
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12203
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Country
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Germany
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Sponsor
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Mandacaru Foundation (Brazil)
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Address
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Rua José Vilar de Andrade 257
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City/town
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Fortaleza
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Zip/Postcode
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CE 60833-830
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Country
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Brazil
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Sponsor website:
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http://www.mandacaru-foundation.org
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Date applied
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16/07/2008
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Last edited
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13/11/2008
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Date ISRCTN assigned
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12/09/2008
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