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
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