Household-wide treatment for the control of head lice infestations in an impoverished community
| ISRCTN | ISRCTN42288908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42288908 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/05/2009
- Registration date
- 29/05/2009
- Last edited
- 29/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hermann Feldmeier
Scientific
Scientific
Institut for Microbiology and Hygiene
Charite-University Medicine Berlin
Campus Benjamin Franklin
Hindenburgdamm 27
Berlin
12203
Germany
Study information
| Study design | Randomised observer-blind controlled trial (single-centre) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Impact of household-wide treatment for the control of head lice infestations in an impoverished community: a randomised observer-blinded controlled trial |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ivermectin |
| Primary outcome measure | 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 study start date | 01/02/2007 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 132 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- Brazil
- Germany
Study participating centre
Institut 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 |
