Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )

February 26, 2019 updated by: Oriol Mitja, Lihir Medical Centre

A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases

This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.

Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.

Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin [IVE] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.

Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a >95% reduction in prevalence sustained for nine months.

Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated.

Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.

Study Type

Interventional

Enrollment (Actual)

20000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to give consent

Exclusion Criteria:

  • Unable to give consent.
  • Less than 5 years of age (not eligible for ivermectin)**
  • Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
  • Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**
  • History of allergies to the drugs being studied
  • Residents who cannot swallow tablets

Note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any AEs attributed to specific drug combinations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Separate Administration
'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'
Drug: Albendazole on Day 1
Albendazole 400 mg oral tablet Single Dose Treatment on D1
Other Names:
  • Albenza
Drug: Ivermectin on Day 1
Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1
Other Names:
  • Mectizan
Drug: Diethylcarbamazine on day 1
Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1
Other Names:
  • Banocide
  • DEC-d1
Drug: Azithromycin on Day 8
Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8
Other Names:
  • Zithromax
Experimental: Co-Administration
'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'
Drug: Albendazole on Day 1
Albendazole 400 mg oral tablet Single Dose Treatment on D1
Other Names:
  • Albenza
Drug: Ivermectin on Day 1
Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1
Other Names:
  • Mectizan
Drug: Diethylcarbamazine on day 1
Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1
Other Names:
  • Banocide
  • DEC-d1
Drug: Azithromycin on Day 1
Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1
Other Names:
  • Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Reported Adverse Event
Time Frame: 7 Days
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.
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lihir Medical Centre

Collaborators

London School of Hygiene and Tropical Medicine

Investigators

  • Principal Investigator: Lucy John, MD, National Department of Health of Papua New Guinea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

September 16, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ComboNTDs - CRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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