NCT01586169

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status
completed
Actual enrollment (reported)
3,000 participants
Study completion date

February 2010

Actual (reported)
Listed locations
1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

  1. Study Start

    February 2010

    Date type not reported

    This date has not been verified as actual or estimated.

  2. Primary Completion

    February 2010

    Actual (reported)

  3. Study Completion

    February 2010

    Actual (reported)

  4. First Submitted

    April 23, 2012

    Actual (reported)

  5. First Posted

    April 26, 2012

    Actual (reported)
Last Updated
April 26, 2012
Status Verified
April 2012
Last Update Submitted
April 24, 2012

Conditions

Parasitic DiseasesBacterial Diseases

Keywords

AlbendazoleIvermectinAzithromycinLymphatic filariasisTrachomaSafety

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

triple co administration at once of the combination of Albendazole + ivermectin + azithromycinDRUG

Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once

Also known as: Albendazole, Mectizan, Zithromax

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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

Parasitic DiseasesBacterial InfectionsElephantiasis, FilarialTrachoma

Interventions

IvermectinAzithromycinAlbendazole

Condition Hierarchy (Ancestors)

InfectionsBacterial Infections and MycosesFilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisMosquito-Borne DiseasesVector Borne DiseasesLymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesConjunctivitis, BacterialEye Infections, BacterialChlamydia InfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsErythromycinCarbamatesAcids, AcyclicCarboxylic AcidsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Samba O Sow, MD, MPH

    CNAM, Mali

    PRINCIPAL INVESTIGATOR

Enrollment

3,000 participants — actual enrollment reported by the registry.

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 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2010

Actual (reported)

Study Completion

February 2010

Actual (reported)

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

MA(1)