Condition category
Infections and Infestations
Date applied
16/07/2008
Date assigned
12/09/2008
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hermann Feldmeier

ORCID ID

Contact details

Institute for Microbiology and Hygiene
Charite - University Medicine Berlin
Campus Benjamin Franklin
Hindenburgdamm 27
Berlin
12203
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

195/02

Study information

Scientific title

Controlling tungiasis in an impoverished community: an intervention study

Acronym

CTIC

Study hypothesis

The implementation of various control measures will result in a drop of prevalence and intensity of infestation of tungiasis.

Ethics approval

Ethical Review Board of the Federal University of Ceará. Date of approval: 25/10/2002 (ref: 195/02)

Study design

Non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

14/11/2002

Overall trial end date

20/11/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

831

Participant exclusion criteria

1. Absence from the study area for more than 4 days per week
2. Unwillingness to participate

Recruitment start date

14/11/2002

Recruitment end date

20/11/2003

Locations

Countries of recruitment

Brazil

Trial participating centre

Institute for Microbiology and Hygiene
Berlin
12203
Germany

Sponsor information

Organisation

Mandacaru Foundation (Brazil)

Sponsor details

Rua José Vilar de Andrade 257
Fortaleza
CE 60833-830
Brazil

Sponsor type

Charity

Website

http://www.mandacaru-foundation.org

Funders

Funder type

Charity

Funder name

Mandacaru Foundation (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/pubmed/18941513

Publication citations

  1. Results

    Pilger D, Schwalfenberg S, Heukelbach J, Witt L, Mencke N, Khakban A, Feldmeier H, Controlling tungiasis in an impoverished community: an intervention study., PLoS Negl Trop Dis, 2008, 2, 10, e324, doi: 10.1371/journal.pntd.0000324.

Additional files

Editorial Notes