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

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.

Study Overview

• Status: Completed
• Conditions: Parasitic Diseases; Bacterial Diseases
• Intervention / Treatment: Drug: triple co administration at once of the combination of Albendazole + ivermectin + azithromycin

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
• Enrollment (Actual): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali
    • Centre National D'Appui a la lutte contre la Maladie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish the incidence of adverse events associated with the mass triple drug administration	From Day 0 to Day 15 post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Establish the incidence of serious adverse events associated with the mass triple drug administration	From Day 0 to Day 15 post treatment

Collaborators and Investigators

• Sponsor: Centre d'Appui à la lutte contre la Maladie
• Collaborators: International Trachoma Initiative
• Investigators: Principal Investigator: Samba O Sow, MD, MPH, CNAM, Mali

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Azithromycin; Ivermectin; Albendazole; Trachoma; Lymphatic filariasis
• Additional Relevant MeSH Terms: Infections; Lymphatic Diseases; Eye Diseases; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Lymphedema; Chlamydiaceae Infections; Eye Infections, Bacterial; Eye Infections; Chlamydia Infections; Conjunctivitis, Bacterial; Bacterial Infections; Filariasis; Elephantiasis, Filarial; Elephantiasis; Parasitic Diseases; Trachoma; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Azithromycin; Ivermectin; Albendazole
• Other Study ID Numbers: CNAM/AZIVAL/01; 0958/FMPOS (Other Identifier: FMPOS)