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Trial record 27 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

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

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ClinicalTrials.gov Identifier: NCT01586169
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : April 26, 2012
Sponsor:
Collaborator:
International Trachoma Initiative
Information provided by (Responsible Party):
Centre d'Appui à la lutte contre la Maladie

Tracking Information
First Submitted Date  ICMJE April 23, 2012
First Posted Date  ICMJE April 26, 2012
Last Update Posted Date April 26, 2012
Study Start Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
Establish the incidence of adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
Establish the incidence of serious adverse events associated with the mass triple drug administration [ Time Frame: From Day 0 to Day 15 post treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Parasitic Diseases
  • Bacterial Diseases
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2012)
3000
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mali
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01586169
Other Study ID Numbers  ICMJE CNAM/AZIVAL/01
0958/FMPOS ( Other Identifier: FMPOS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre d'Appui à la lutte contre la Maladie
Study Sponsor  ICMJE Centre d'Appui à la lutte contre la Maladie
Collaborators  ICMJE International Trachoma Initiative
Investigators  ICMJE
Principal Investigator: Samba O Sow, MD, MPH CNAM, Mali
PRS Account Centre d'Appui à la lutte contre la Maladie
Verification Date April 2012

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