Trial record 16 of 21 for:    "Trachoma"

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
  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

Resource links provided by NLM:


Further study details as provided by Centre d'Appui à la lutte contre la Maladie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    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
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

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586169

Locations
Mali
Centre National D'Appui a la lutte contre la Maladie
Bamako, Mali
Sponsors and Collaborators
Centre d'Appui à la lutte contre la Maladie
International Trachoma Initiative
Investigators
Principal Investigator: Samba O Sow, MD, MPH CNAM, Mali
  More Information

No publications provided by Centre d'Appui à la lutte contre la Maladie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Trachoma
Bacterial Infections
Elephantiasis, Filarial
Elephantiasis
Filariasis
Parasitic Diseases
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 April 15, 2014