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

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

A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

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

  • Papua New Guinea
    • New Ireland Province
      • Londolovit, New Ireland Province, Papua New Guinea, 034
        • Lihir Medical Centre

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Azithromycin for Yaws
Patients will receive standard treatment for yaws alone
Drug: Azithromycin
Treatment with Azithromycin single dose - weight based dosing max 2gm
Active Comparator: IDA for Lymphatic Filariasis
Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone
Drug: Albendazole

Single dose of Albendazole weight based dosing

- 400mg

Other Names:
  • IDA
Drug: Ivermectin
Ivermectin weight based dosing - max 21mg
Other Names:
  • IDA
Drug: Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg
Other Names:
  • IDA
Experimental: Combination Therapy of Azithromycin for Yaws and IDA for LF
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
Drug: Azithromycin
Treatment with Azithromycin single dose - weight based dosing max 2gm
Drug: Albendazole

Single dose of Albendazole weight based dosing

- 400mg

Other Names:
  • IDA
Drug: Ivermectin
Ivermectin weight based dosing - max 21mg
Other Names:
  • IDA
Drug: Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg
Other Names:
  • IDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
Time Frame: 4 Days
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
4 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Four days

Collaborators and Investigators

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

Sponsor

Lihir Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ComboNTDs-PK

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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