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

NCT ID: NCT01586169

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-02-28

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.

Conditions

Parasitic Diseases; Bacterial Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Albendazole; Mectizan; Zithromax

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Trachoma Initiative

OTHER

Sponsor Role: collaborator

Centre d'Appui à la lutte contre la Maladie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samba O Sow, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

CNAM, Mali

Locations

Centre National D'Appui a la lutte contre la Maladie

Bamako, Mali, Mali

Countries

Mali

References

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.

Reference Type: DERIVED

PMID: 23675549 (View on PubMed)

Other Identifiers

0958/FMPOS

Identifier Type: OTHER

Identifier Source: secondary_id

CNAM/AZIVAL/01

Identifier Type: -

Identifier Source: org_study_id