Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination

Parasitic Diseases Clinical Trial

— AZIVAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586169
• Other study ID #: CNAM/AZIVAL/01
• Secondary ID: 0958/FMPOS
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: April 24, 2012
• Start date: February 2010
• Est. completion date: February 2010

Study information

• Verified date: April 2012
• Source: Centre d'Appui à la lutte contre la Maladie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: comités d'éthique
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Diseases
• Bacterial Infections
• Filariasis
• Parasitic Diseases
• Trachoma

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

Locations

Country	Name	City	State
Mali	Centre National D'Appui a la lutte contre la Maladie	Bamako

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Appui à la lutte contre la Maladie	International Trachoma Initiative

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the incidence of adverse events associated with the mass triple drug administration		From Day 0 to Day 15 post treatment	Yes
Secondary	Establish the incidence of serious adverse events associated with the mass triple drug administration		From Day 0 to Day 15 post treatment	Yes