Clinical trial NCT01586169: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parasitic Diseases
Bacterial Diseases
Keywords: Albendazole
Ivermectin
Azithromycin
Lymphatic filariasis
Trachoma
Safety
Lead sponsor: Centre d'Appui à la lutte contre la Maladie
Sponsor class: OTHER
Collaborators: name: International Trachoma Initiative
First posted: 2012-04-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Establish the incidence of adverse events associated with the mass triple drug administration
timeFrame: From Day 0 to Day 15 post treatment
Secondary outcomes:
measure: Establish the incidence of serious adverse events associated with the mass triple drug administration
timeFrame: From Day 0 to Day 15 post treatment
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: Centre National D'Appui a la lutte contre la Maladie
Study officials:
affiliation: CNAM, Mali
name: Samba O Sow, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.