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

Sponsor
Lihir Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT03664063
Collaborator
(none)
42
Enrollment
1
Location
3
Arms
4
Actual Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole [4 Days]

      Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lihir Medical Centre Londolovit New Ireland Province Papua New Guinea 034

    Sponsors and Collaborators

    • Lihir Medical Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oriol Mitja, Associate Professor, Lihir Medical Centre
    ClinicalTrials.gov Identifier:
    NCT03664063
    Other Study ID Numbers:
    • ComboNTDs-PK
    First Posted:
    Sep 10, 2018
    Last Update Posted:
    Feb 28, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Filariasis
    Elephantiasis, Filarial
    Elephantiasis
    Azithromycin
    Ivermectin
    Albendazole
    Diethylcarbamazine

    Study Results

    No Results Posted as of Feb 28, 2019