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Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

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ClinicalTrials.gov Identifier: NCT03570814
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Armauer Hansen Research Institute, Ethiopia
Federal Minstry of Health of Ethiopia
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.


Condition or disease Intervention/treatment Phase
Trachoma Lymphatic Filariases Drug: Administration of Albendazole on Day 1 Drug: Administration of Ivermectin on Day 1 Drug: Administration of Azithromycin on Day 1 Drug: Administration of Azithromycin on Day 15 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomised trial. Approximately 40 clusters per study arm
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: Separate Administration
Standard administration of Albendazole/Ivermectin separated from administration of azithromycin
Drug: Administration of Albendazole on Day 1
Participants will receive Albendazole 400mg on study day 1.

Drug: Administration of Ivermectin on Day 1
Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole.

Drug: Administration of Azithromycin on Day 15
Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 15. Doses of Azithromycin will be determined using a standard dosing pole.

Experimental: Co-administration
Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point
Drug: Administration of Albendazole on Day 1
Participants will receive Albendazole 400mg on study day 1.

Drug: Administration of Ivermectin on Day 1
Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole.

Drug: Administration of Azithromycin on Day 1
Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 1. Doses of Azithromycin will be determined using a standard dosing pole.




Primary Outcome Measures :
  1. Self Reported Adverse Event [ Time Frame: 1 Month ]
    The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms,


Secondary Outcome Measures :
  1. Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs [ Time Frame: 1 month ]
    Analysis of the cost effectiveness of co-administration compared to separate administration of drugs

  2. Community perceptions [ Time Frame: 1 month ]
    An analysis of community perceptions of benefits of co-administration at a single time point vs standard separated MDA will be conducted by conducting focus groups and in-depth interviews with study participants.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570814


Contacts
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Contact: Michael Marks, PhD +447984643424 michael.marks@lshtm.ac.uk

Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Armauer Hansen Research Institute, Ethiopia
Federal Minstry of Health of Ethiopia

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03570814     History of Changes
Other Study ID Numbers: 11985
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chlamydia Infections
Trachoma
Filariasis
Elephantiasis, Filarial
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Ivermectin
Albendazole
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents