A Pharmacovigilance Study on the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults Living in the Sikasso Region of Mali
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Establish the incidence of adverse events associated with the mass triple drug administration
Study Overview
Brief Summary
The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.
Detailed Description
Infectious diseases such as trachoma and lymphatic filariasis are public health problems in regions of Africa and Asia. Elimination programs exist for the two diseases, and their treatment by different groups of health workers is both costly and inefficient.
Thus, a study evaluating the safety and feasibility of an integrated mass treatment of trachoma and lymphatic filariasis with azithromycin associated with albendazole and ivermectin was instituted in 4 villages of the region of Sikasso in Mali (West Africa) co endemic for lymphatic filariasis and trachoma.
It was an open label randomized clusters type on the assessment of the safety of the triple co administration of azithromycin, ivermectin and albendazole (experimental regimen) as compared to the administration of the co administration of albendazole plus ivermectin followed by the that of azithromycin a week later (current standard recommended regimen) within subjects of 5 to 65 years old, willing and able to swallow the study drugs.
Clinical evaluation of adverse events in all study participants was done on day 0, day 8, and day 15 after the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must have been residing in the village for at least three months;
- •Must be 90 cm tall or more;
- •Must be between 5 years and 65 years of age;
- •Must not be pregnant;
- •Must not be lactating.
Exclusion Criteria
- •Subjects under 5 years of age or less than 90 cm in height;
- •Subjects over 65 years of age;
- •Subjects who cannot swallow tablets;
- •Subjects who are sick and bedridden;
- •Pregnant women (clinical appreciation in the study);
- •Lactating women;
- •History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole).
Outcomes
Primary Outcomes
Establish the incidence of adverse events associated with the mass triple drug administration
Time Frame: From Day 0 to Day 15 post treatment
Secondary Outcomes
- Establish the incidence of serious adverse events associated with the mass triple drug administration(From Day 0 to Day 15 post treatment)