Condition category
Infections and Infestations
Date applied
09/05/2009
Date assigned
29/05/2009
Last edited
29/05/2009
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

Institut 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

N/A

Study information

Scientific title

Impact of household-wide treatment for the control of head lice infestations in an impoverished community: a randomised observer-blinded controlled trial

Acronym

Study hypothesis

Children of families that had received household-wide head lice treatment with ivermectin remain longer without head lice infestation than children of families without treatment.

Ethics approval

Ethical Review Board of the Federal University of Ceará approved on the 14th September 2006 (ref: 179/06). Registered in the database of the Brazilian Ministry of Health for studies involving human subjects.

Study design

Randomised observer-blind controlled trial (single-centre)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Active head lice infestation

Intervention

Participants (sentinels) were recruted in a holiday resort outside the endemic area where another trial had taken place immediately before the study. While still in the holiday resort but immediately before entering the study, participants had received oral ivermectin. In addition, baseline head lice status was assessed by vigorous wet-combing.

Households of the participating children were randomised into two groups. In the intervention group, all household members (except the head lice-free sentinels) were treated orally with ivermectin (200 µg/kg; Revectina®, Solvay Farma, Brazil) the day before the sentinels returned to their families. Treatment was repeated after 10 days. Household members of the control group remained untreated. A day after the household-wide treatment the sentinels returned from the holiday resort and were examined for the presence of head lice by wet combing every three to four days, during a period of 60 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ivermectin

Primary outcome measures

The median infestation-free period, defined as the days between baseline and the first head lice positive examination during follow-up visits. A positive head lice examination was defined as the detection of at least one viable head louse or nymph determined by diagnostic wet-combing.

Secondary outcome measures

Analyses on individual characteristics (sex, hair length and type) and characteristics of the households (poverty, crowding) were done to measure their importance for infestation-free periods. The annual incidence was calculated/estimated.

Overall trial start date

01/02/2007

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 5 - 15 years, either sex
2. Absence of active head lice infestation determined by diagnostic wet-combing
3. Written consent obtained from the study participants and carers

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

132

Participant exclusion criteria

1. Active head lice infestation during baseline examination (defined as the detection of at least one viable head louse or nymph after vigorous wet-combing)
2. Absence from the study area for more than a week
3. Unwillingess to participate in the study

Recruitment start date

01/02/2007

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Brazil

Trial participating centre

Institut 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

Publication citations

Additional files

Editorial Notes