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
2 other identifiers
interventional
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedApril 26, 2012
April 1, 2012
Same day
April 23, 2012
April 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establish the incidence of adverse events associated with the mass triple drug administration
From Day 0 to Day 15 post treatment
Secondary Outcomes (1)
Establish the incidence of serious adverse events associated with the mass triple drug administration
From Day 0 to Day 15 post treatment
Interventions
Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre National D'Appui a la lutte contre la Maladie
Bamako, Mali, Mali
Related Publications (1)
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.
PMID: 23675549DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samba O Sow, MD, MPH
CNAM, Mali
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2012
First Posted
April 26, 2012
Study Start
February 1, 2010
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
April 26, 2012
Record last verified: 2012-04