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Trial record 28 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date August 13, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
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,
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03570814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
  • 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
  • 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.
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 Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Trachoma
  • Lymphatic Filariases
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Separate Administration
    Standard administration of Albendazole/Ivermectin separated from administration of azithromycin
    Interventions:
    • Drug: Administration of Albendazole on Day 1
    • Drug: Administration of Ivermectin on Day 1
    • Drug: Administration of Azithromycin on Day 15
  • Experimental: Co-administration
    Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point
    Interventions:
    • Drug: Administration of Albendazole on Day 1
    • Drug: Administration of Ivermectin on Day 1
    • Drug: Administration of Azithromycin on Day 1
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2018)
16000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Marks, PhD +447984643424 michael.marks@lshtm.ac.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03570814
Other Study ID Numbers  ICMJE 11985
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Armauer Hansen Research Institute, Ethiopia
  • Federal Minstry of Health of Ethiopia
Investigators  ICMJE Not Provided
PRS Account London School of Hygiene and Tropical Medicine
Verification Date February 2019

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