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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664063
• Other study ID #: ComboNTDs-PK
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: February 2019
• Source: Lihir Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Filariasis
• Lymphatic Filariasis
• Trauma
• Yaws

Intervention

Drug:
• Azithromycin
Treatment with Azithromycin single dose - weight based dosing max 2gm
• Albendazole
Single dose of Albendazole weight based dosing - 400mg
• Ivermectin
Ivermectin weight based dosing - max 21mg
• Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg

Locations

Country	Name	City	State
Papua New Guinea	Lihir Medical Centre	Londolovit	New Ireland Province

Sponsors (1)

Lead Sponsor	Collaborator
Lihir Medical Centre

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole	Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole	4 Days
Secondary	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	Four days