Centre National D'Appui a la lutte contre la Maladie
Bamako, Mali
NCT Number: NCT01586169
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.
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Notify Me5 year–65 year
All sexes
Interventional
Not applicable
Bamako, Mali
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once
Other names: Albendazole, Mectizan, Zithromax
Time frame: From Day 0 to Day 15 post treatment
Time frame: From Day 0 to Day 15 post treatment
Centre d'Appui à la lutte contre la Maladie
Other
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
Acronym: AZIVAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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