Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination (AZIVAL)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parasitic Diseases Bacterial Diseases |
Drug: triple co administration at once of the combination of Albendazole + ivermectin + azithromycin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ]
- 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 ]
| Enrollment: | 3000 |
| Study Start Date: | February 2010 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
-
Drug: triple co administration at once of the combination of Albendazole + ivermectin + azithromycin
- Albendazole
- Mectizan
- Zithromax
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| Ages Eligible for Study: | 5 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Mali | |
| Centre National D'Appui a la lutte contre la Maladie | |
| Bamako, Mali | |
| Principal Investigator: | Samba O Sow, MD, MPH | CNAM, Mali |
More Information
No publications provided
| Responsible Party: | Centre d'Appui à la lutte contre la Maladie |
| ClinicalTrials.gov Identifier: | NCT01586169 History of Changes |
| Other Study ID Numbers: | CNAM/AZIVAL/01, 0958/FMPOS |
| Study First Received: | April 23, 2012 |
| Last Updated: | April 24, 2012 |
| Health Authority: | Mali: comités d'éthique |
Keywords provided by Centre d'Appui à la lutte contre la Maladie:
|
Albendazole Ivermectin Azithromycin |
Lymphatic filariasis Trachoma Safety |
Additional relevant MeSH terms:
|
Bacterial Infections Elephantiasis, Filarial Elephantiasis Filariasis Parasitic Diseases Trachoma Spirurida Infections Secernentea Infections Nematode Infections Helminthiasis Lymphedema Lymphatic Diseases Conjunctivitis, Bacterial Eye Infections, Bacterial Chlamydia Infections |
Chlamydiaceae Infections Gram-Negative Bacterial Infections Eye Infections Infection Conjunctivitis Conjunctival Diseases Eye Diseases Corneal Diseases Albendazole Ivermectin Azithromycin Anticestodal Agents Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 21, 2013