NCT03664063

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Lihir Medical Centre · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lymphatic Filariasis
• Yaws
• Trauma

Interventions

Type	Name	Description
DRUG	Azithromycin	Treatment with Azithromycin single dose - weight based dosing max 2gm
DRUG	Albendazole	Single dose of Albendazole weight based dosing \- 400mg
DRUG	Ivermectin	Ivermectin weight based dosing - max 21mg
DRUG	Diethylcarbamazine	Diethylcarbamazine weight based dosing - max 500mg

Timeline

• Start date: 2018-09-01
• Primary completion: 2018-10-01
• Completion: 2019-01-01
• First posted: 2018-09-10
• Last updated: 2019-02-28

Locations

1 site across 1 country: Papua New Guinea