Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination (AZIVAL)
|ClinicalTrials.gov Identifier: NCT01586169|
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : April 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Parasitic Diseases Bacterial Diseases||Drug: triple co administration at once of the combination of Albendazole + ivermectin + azithromycin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Drug: triple co administration at once of the combination of Albendazole + ivermectin + azithromycin
- Establish the incidence of adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ]
- Establish the incidence of serious adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586169
|Centre National D'Appui a la lutte contre la Maladie|
|Principal Investigator:||Samba O Sow, MD, MPH||CNAM, Mali|