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CompletedNCT01586169AZIVALUpdated Apr 26, 2012

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

An interventional study of triple co administration at once of the combination of Albendazole + ivermectin + azithromycin in Parasitic Diseases and Bacterial Diseases, sponsored by Centre d'Appui à la lutte contre la Maladie. Completed at 1 site in Mali. Open to participants aged 5 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-04-26.

Primary conditionElephantiasis, FilarialRegistry: Parasitic DiseasesReclassifiedWhy we changed it
Registry
Parasitic Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Elephantiasis, Filarial
Why
  1. The study's title name Elephantiasis, Filarial, a narrower term within Parasitic Diseases.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre d'Appui à la lutte contre la Maladie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Not applicable
Ages
5 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parasitic Diseases
  • Bacterial Diseases

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Keywords

  • Albendazole
  • Ivermectin
  • Azithromycin
  • Lymphatic filariasis
  • Trachoma
  • Safety
03

In context

Elephantiasis, Filarial Reclassified

42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.

This study's enrollment of 3,000 is above the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.

Browse Elephantiasis, Filarial studies →

Lead sponsor

Centre d'Appui à la lutte contre la Maladie is the lead sponsor of 2 studies on the registry; none are open to participants now.

Compared within Elephantiasis, Filarial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Parasitic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
5 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,000 participants (actual)

Interventions

  • Drugtriple co administration at once of the combination of Albendazole + ivermectin + azithromycin

    Drug page: Albendazole

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

    Also known as: Albendazole, Mectizan, Zithromax

06

What researchers measure

Primary outcomes

  1. Establish the incidence of adverse events associated with the mass triple drug administration

    Time frame: 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

    Time frame: From Day 0 to Day 15 post treatment

07

Study locations

1 site
  • Centre National D'Appui a la lutte contre la Maladie
    Bamako, Mali
08

References and documents

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. PubMed 23675549 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of Feb 2010 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2012
First posted
Apr 26, 2012
Start
Feb 2010
Primary completionActual
Feb 2010
CompletionActual
Feb 2010
Last update
Apr 26, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01586169
Lead sponsor
Centre d'Appui à la lutte contre la Maladie
Collaborators
International Trachoma Initiative
Responsible party
Sponsor
First posted
Apr 26, 2012
Start date
Feb 2010
Primary completion
Feb 2010
Completion
Feb 2010
Last update
Apr 26, 2012

Study contacts

Samba O Sow, MD, MPH
principal investigator · CNAM, Mali

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Albendazole

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