None listed
Conditions
Brief summary
This study is designed to evaluate the feasibility and safety of co-administration of azithromycin and ivermectin in large populations in these settings and to provide data to support co-administration in other settings. Alongside this the study aims to evaluate the effectiveness of large scale ivermectin-based MDA for scabies and to addresses the problem of how to scale up MDA for scabies control in high prevalence countries, and specifically in settings where there is already an infrastructure and established need for trachoma MDA.
Interventions
This is a single arm prospective community intervention trial.
Participants will be invited to take part in a joint MDA program for trachoma and scabies, with the first trachoma MDA dose at the same time as the first of two scabies MDA doses.
All participants are offered the same treatment regardless of the presence or absence of clinical signs of trachoma or scabies at the time of the intervention.
Trachoma MDA: Participants will be offered 1 oral dose of azithromycin (directly observed) at 2
This is a single arm prospective community intervention trial. Participants will be invited to take part in a joint MDA program for trachoma and scabies, with the first trachoma MDA dose at the same time as the first of two scabies MDA doses. All participants are offered the same treatment regardless of the presence or absence of clinical signs of trachoma or scabies at the time of the intervention. Trachoma MDA: Participants will be offered 1 oral dose of azithromycin (directly observed) at 20 mg/kg, up to a maximum of 1 gm. Pregnant women will be offered a choice of azithromycin or 1% topical tetracycline (twice daily application to the eye for 3 weeks). Individuals aged less than 6 months will be offered topical tetracycline at the same dose as pregnant women. Scabies MDA: Participants will be offered 2 doses of oral ivermectin (directly observed) at 200 micrograms/kg 7 days apart. Participants for whom ivermectin is contra-indicated will be offered 2 doses of topical 5% permethrin cream 7 days apart. Topical permethrin will be applied to the whole body in line with standard treatment of scabies. In a subset of randomly selected villages individuals will undergo a skin check to collect baseline data on the prevalence of scabies and impetigo. Diagnosis is made clinically and no samples are collected. Procedures in these villages are otherwise identical with regards to the MDA intervention.
Sponsors
Murdoch Childrens Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
Yes
Inclusion criteria
All community members resident in Choiseul province, Solomon Islands able to be included in the study. Treatment is offered to all individuals regardless of the presence/absence of scabies/impetigo/trachoma at the time of MDA.
Exclusion criteria
- Allergy to any of the components of the allocated drug regimen - Currently on, or has taken ivermectin in the previous 7 days - Clinical diagnosis of crusted scabies: participants with severe or crusted scabies will be treated with 2 doses of ivermectin (except if ivermectin is contraindicated as outlined above) in conjunction with twice weekly permethrin cream for 1 month, with review at 1,2,3,12 and 24 months. Efforts will be made to control these cases intensively to prevent the high force of infection associated with these crusted cases from diminishing the effect of the MDA.
Outcome results
None listed