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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Self Reported Adverse Event


Condition

Trachoma

Intervention

Albendazole on Day 1

Study Arms / Comparison Groups

 Separate Administration
Description:  'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'

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

20000

Start Date

October 1, 2018

Completion Date

January 1, 2019

Primary Completion Date

December 15, 2018

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Lucy John, MD, , 

Location Countries

Papua New Guinea

Location Countries

Papua New Guinea

Administrative Informations


NCT ID

NCT03676140

Organization ID

ComboNTDs - CRT


Responsible Party

Principal Investigator

Study Sponsor

Lihir Medical Centre

Collaborators

 London School of Hygiene and Tropical Medicine

Study Sponsor

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


Verification Date

February 2019