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

Primary Purpose

Lymphatic Filariasis, Yaws, Trauma

Status
Completed
Phase
Phase 2
Locations
Papua New Guinea
Study Type
Interventional
Intervention
Azithromycin
Albendazole
Ivermectin
Diethylcarbamazine
Sponsored by
Lihir Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Filariasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lihir Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Azithromycin for Yaws

IDA for Lymphatic Filariasis

Combination Therapy of Azithromycin for Yaws and IDA for LF

Arm Description

Patients will receive standard treatment for yaws alone

Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone

Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.

Outcomes

Primary Outcome Measures

Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2018
Last Updated
February 26, 2019
Sponsor
Lihir Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03664063
Brief Title
PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )
Official Title
A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lihir Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Filariasis, Yaws, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin for Yaws
Arm Type
Active Comparator
Arm Description
Patients will receive standard treatment for yaws alone
Arm Title
IDA for Lymphatic Filariasis
Arm Type
Active Comparator
Arm Description
Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone
Arm Title
Combination Therapy of Azithromycin for Yaws and IDA for LF
Arm Type
Experimental
Arm Description
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Treatment with Azithromycin single dose - weight based dosing max 2gm
Intervention Type
Drug
Intervention Name(s)
Albendazole
Other Intervention Name(s)
IDA
Intervention Description
Single dose of Albendazole weight based dosing - 400mg
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
IDA
Intervention Description
Ivermectin weight based dosing - max 21mg
Intervention Type
Drug
Intervention Name(s)
Diethylcarbamazine
Other Intervention Name(s)
IDA
Intervention Description
Diethylcarbamazine weight based dosing - max 500mg
Primary Outcome Measure Information:
Title
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
Description
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
Time Frame
4 Days
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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
Time Frame
Four days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Lihir Medical Centre
City
Londolovit
State/Province
New Ireland Province
ZIP/Postal Code
034
Country
Papua New Guinea

12. IPD Sharing Statement

Citations:
PubMed Identifier
32818264
Citation
John LN, Bjerum C, Martinez PM, Likia R, Silus L, Wali C, Elizah A, Chhonker YS, Bala V, King CL, Murry DJ, Mitja O, Marks M. Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases. Clin Infect Dis. 2020 Aug 20:ciaa1202. doi: 10.1093/cid/ciaa1202. Online ahead of print.
Results Reference
derived

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

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