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

This study has been completed.
Sponsor:
Collaborator:
International Trachoma Initiative
Information provided by (Responsible Party):
Centre d'Appui à la lutte contre la Maladie
ClinicalTrials.gov Identifier:
NCT01586169
First received: April 23, 2012
Last updated: April 24, 2012
Last verified: April 2012

April 23, 2012
April 24, 2012
February 2010
February 2010   (final data collection date for primary outcome measure)
Establish the incidence of adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01586169 on ClinicalTrials.gov Archive Site
Establish the incidence of serious adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Parasitic Diseases
  • Bacterial Diseases
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
Not Provided
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 May.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
February 2010
February 2010   (final data collection date for primary outcome measure)

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).
Both
5 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Mali
 
NCT01586169
CNAM/AZIVAL/01, 0958/FMPOS
Yes
Centre d'Appui à la lutte contre la Maladie
Centre d'Appui à la lutte contre la Maladie
International Trachoma Initiative
Principal Investigator: Samba O Sow, MD, MPH CNAM, Mali
Centre d'Appui à la lutte contre la Maladie
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP