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
• Sponsor: Centre d'Appui à la lutte contre la Maladie
• Collaborator: International Trachoma Initiative
• Information provided by (Responsible Party): Centre d'Appui à la lutte contre la Maladie

Tracking Information

• First Submitted Date: April 23, 2012
• First Posted Date: April 26, 2012
• Last Update Posted Date: April 26, 2012
• Study Start Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 24, 2012): Establish the incidence of adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: April 24, 2012): Establish the incidence of serious adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination
• 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Parasitic Diseases
• Bacterial Diseases

Intervention

Drug: triple co administration at once of the combination of Albendazole + ivermectin + azithromycin

Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once

Other Names:

• Albendazole
• Mectizan
• Zithromax

• Study Arms: Not Provided
• Publications *: Coulibaly YI, Dicko I, Keita M, Keita MM, Doumbia M, Daou A, Haidara FC, Sankare MH, Horton J, Whately-Smith C, Sow SO. A cluster randomized study of the safety of integrated treatment of trachoma and lymphatic filariasis in children and adults in Sikasso, Mali. PLoS Negl Trop Dis. 2013 May 9;7(5):e2221. doi: 10.1371/journal.pntd.0002221. Print 2013.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 24, 2012): 3000
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mali

Administrative Information

• NCT Number: NCT01586169
• Other Study ID Numbers: CNAM/AZIVAL/01; 0958/FMPOS ( Other Identifier: FMPOS )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Centre d'Appui à la lutte contre la Maladie
• Study Sponsor: Centre d'Appui à la lutte contre la Maladie
• Collaborators: International Trachoma Initiative

Investigators

• Principal Investigator: Samba O Sow, MD, MPH; CNAM, Mali

• PRS Account: Centre d'Appui à la lutte contre la Maladie
• Verification Date: April 2012