Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

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Brief Title

Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

Official Title

Safety of the Co-administration of Azithromycin, Albendazole and Ivermectin Versus Standard Treatment Regimens During Mass Drug Administration (MDA) in Ethiopia: a Cluster-randomized Trial

Brief Summary

      Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole
      with separate administration of Azithromycin and Ivermectin/Albendazole.

      The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Within this district, a
      study group of 8,000 people (in approximately 40 clusters) will receive the azithromycin,
      ivermectin & albendazole at a single time. A control group of 8,000 people (in approximately
      40 clusters) within the same district will receive the current MDA treatment schedule
      beginning with Ivermectin/Albendazole followed two weeks later with azithromycin. All drug
      dosing will be in line with standard FMOH and WHO Guidelines for MDA for trachoma and
      lymphatic filariasis.

      The study will randomly sort subdistrict communities (Gotes) into the trial arm and the
      control arm. The study will compare the number of adverse events (AEs) and severe adverse
      events (SAEs) between the two arms to determine if co-administration is not inferior to the
      standard treatment. The primary outcome will be to demonstrate the safety of the triple-drug
      administration as measured by incidence of AEs/SAEs following the MDA.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Self Reported Adverse Event

Secondary Outcome

 Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs

Condition

Trachoma

Intervention

Administration of Albendazole on Day 1

Study Arms / Comparison Groups

 Separate Administration
Description:  Standard administration of Albendazole/Ivermectin separated from administration of azithromycin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

16000

Start Date

August 2021

Completion Date

July 2022

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Residing in the community for at least three months;

          2. Eligible to receive all three agents according to standard MDA criteria

        Exclusion Criteria:

          1. Not eligible to receive one or more drugs according to standard MDA criteria;

          2. Less than 5 years of age (not eligible for ivermectin)**

          3. Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)

          4. Lactating women (Only administered azithromycin and albendazole, not eligible for
             ivermectin)**

          5. History of allergies to the drugs being studied (azithromycin, ivermectin,
             albendazole)

          6. Residents who cannot swallow tablets

               -  Note that patients that are not eligible for IVM, will receive azithromycin and
                  albendazole. Patients that receive azithromycin and albendazole will be followed
                  up through the same procedure as the triple drug therapy to try to track any AEs
                  attributed to the two drug combination.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, +447984643424, [email protected]



Administrative Informations


NCT ID

NCT03570814

Organization ID

11985


Responsible Party

Sponsor

Study Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

 Armauer Hansen Research Institute, Ethiopia

Study Sponsor

, , 


Verification Date

September 2020