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Trial record 56 of 102 for:    IVERMECTIN

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

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ClinicalTrials.gov Identifier: NCT03664063
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Oriol Mitja, Lihir Medical Centre

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
Lymphatic Filariasis Yaws Trauma Drug: Azithromycin Drug: Albendazole Drug: Ivermectin Drug: Diethylcarbamazine Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : September 1, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : January 1, 2019


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 Name: IDA

Drug: Ivermectin
Ivermectin weight based dosing - max 21mg
Other Name: IDA

Drug: Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg
Other Name: 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 Name: IDA

Drug: Ivermectin
Ivermectin weight based dosing - max 21mg
Other Name: IDA

Drug: Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg
Other Name: IDA




Primary Outcome Measures :
  1. Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole [ Time Frame: 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 [ 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664063


Locations
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Papua New Guinea
Lihir Medical Centre
Londolovit, New Ireland Province, Papua New Guinea, 034
Sponsors and Collaborators
Lihir Medical Centre

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Responsible Party: Oriol Mitja, Associate Professor, Lihir Medical Centre
ClinicalTrials.gov Identifier: NCT03664063     History of Changes
Other Study ID Numbers: ComboNTDs-PK
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ivermectin
Filariasis
Elephantiasis, Filarial
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Albendazole
Diethylcarbamazine
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Filaricides
Antinematodal Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors