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Completed

NCT Number: NCT03664063

PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.

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Key information

Conditions

Lymphatic Filariasis Bacterial Infections Bacterial Infections and Mycoses Elephantiasis, Filarial Filariasis Gram-Negative Bacterial Infections Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphedema Mosquito-Borne Diseases Nematode Infections Parasitic Diseases Secernentea Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Spirochaetales Infections Spirurida Infections Trauma Treponemal Infections Vector Borne Diseases Wounds and Injuries Yaws

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lihir Medical Centre

Londolovit, New Ireland Province, 034, Papua New Guinea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult aged 18-65
  • Able to give informed consent

Exclusion criteria

  • Known chronic illness
  • Hb <7 at baseline
  • Liver function or Creatinine * 1.5 Upper Limit of Normal
  • Urinary tract infection at baseline
  • Pregnancy (female participants only)
  • Routine medications which interact with study drugs
  • Lactose/Gluten intolerance
  • Permanent disability impeding study participation

Treatment and study plan

Azithromycin

Drug

Treatment with Azithromycin single dose - weight based dosing max 2gm

Albendazole

Drug

Single dose of Albendazole weight based dosing

  • 400mg

Other names: IDA

Ivermectin

Drug

Ivermectin weight based dosing - max 21mg

Other names: IDA

Diethylcarbamazine

Drug

Diethylcarbamazine weight based dosing - max 500mg

Other names: IDA

Primary outcomes

  1. Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole

    Time frame: 4 Days

    Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Four days

    Patients will undergo regular monitoring for the duration of the study - adverse events will be graded from 1 to 4 in line with the CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Lihir Medical Centre

Other

Registry information

Official study title

A Pharmacokinetic and Pharmacodynamic Evaluation 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 10, 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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