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Completed

NCT Number: NCT03676140

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

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.

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Key information

Conditions

Trachoma Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Corneal Diseases Disease Attributes Ectoparasitic Infestations Elephantiasis, Filarial Eye Diseases Eye Infections Eye Infections, Bacterial Filariasis Gram-Negative Bacterial Infections Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphatic Filariases Lymphedema Mite Infestations Mosquito-Borne Diseases Neglected Diseases Nematode Infections Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rhabditida Infections Scabies Secernentea Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Spirochaetales Infections Spirurida Infections Strongyloidiasis Treponemal Infections Vector Borne Diseases Yaws

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Namatanai Hospital

Namatanai, Papua New Guinea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albendazole on Day 1

Drug

Albendazole 400 mg oral tablet Single Dose Treatment on D1

Other names: Albenza

Ivermectin on Day 1

Drug

Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1

Other names: Mectizan

Diethylcarbamazine on day 1

Drug

Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1

Other names: DEC-d1, Banocide

Azithromycin on Day 1

Drug

Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1

Other names: Zithromax

Azithromycin on Day 8

Drug

Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8

Other names: Zithromax

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Lihir Medical Centre

Other

Collaborators

  • London School of Hygiene and Tropical Medicine

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 18, 2018
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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