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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03664063

Enrollment

Registered

2018-09-10

Start date

2018-09-01

Completion date

2019-01-01

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic Filariasis, Trauma, Yaws

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.

Interventions

DRUGAzithromycin

Treatment with Azithromycin single dose - weight based dosing max 2gm

DRUGAlbendazole

Single dose of Albendazole weight based dosing \- 400mg

DRUGIvermectin

Ivermectin weight based dosing - max 21mg

DRUGDiethylcarbamazine

Diethylcarbamazine weight based dosing - max 500mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Papua New Guinea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026