Parasitic Diseases Clinical Trial
Official title:
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
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.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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